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Jul 05, 2023

FDA releases February 2016 510(k) clearances

April 5, 2016 By MassDevice 510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016. TOTAL 510(k)s THIS PERIOD 224TOTAL WITH SUMMARIES 213TOTAL WITH

April 5, 2016 By MassDevice

510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016.

TOTAL 510(k)s THIS PERIOD 224TOTAL WITH SUMMARIES 213TOTAL WITH STATEMENTS 11

February 2016 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016

DEVICE: ANI MonitorMDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional)ATTN: MATHILDE COLLET PHONE NO : 011 333 620920816, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG 510(k) NO: K143290(Traditional)ATTN: Oliver Lange PHONE NO : 49 07142 7050Hopfigheimer Strasse 17 SE DECISION MADE: 18-FEB-16Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIARS SCREWSOVERMED SRL. 510(k) NO: K143596(Traditional)ATTN: DAVIDE PIZZAMIGLIO PHONE NO : 39 02 45712515VIA LUCANIA 23 BUCCINASCO SE DECISION MADE: 05-FEB-16MILAN IT 20090 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AnapnoGuard 100 Respiratory Guard SystemHOSPITECH RESPIRATION LTD. 510(k) NO: K150157(Traditional)ATTN: Yoram Levy PHONE NO : 972 3 919164820 HAMAGSHIMIM ST. KIRYAT MATALON SE DECISION MADE: 16-FEB-16PETACH TIKVA IL 49348 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Pain Therapy System, Model PTS-IICOUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K150277(Traditional)ATTN: Eagle Eagle PHONE NO : 86 20 382899802ND &3RD FLOOR, BLD. 6, DAPIAN INDSE DECISION MADE: 12-FEB-16GUANGZHOU CN 510665 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Oxyless Blood Tubing SetOxyless Ltd 510(k) NO: K150304(Abbreviated)ATTN: Bob Duffy PHONE NO : 440 207383 9888Third Floor, Bewlay House, 2 SwallSE DECISION MADE: 24-FEB-16London GB 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG 510(k) NO: K150468(Traditional)ATTN: Harald Jung PHONE NO : 49 7462 94799182Unter Buchsteig 5 SE DECISION MADE: 29-FEB-16Tuttlingen DE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-Suit NIR Biliary Metallic StentMEDINOL LTD. 510(k) NO: K150487(Traditional)ATTN: Michal Hershkovitz PHONE NO : 972 3 7679000KIRYAT ATIDIM, BUILDING 8 SE DECISION MADE: 12-FEB-16TEL AVIV IL 6158101 510(k) STATEMENT

DEVICE: Ora-GUARD Dental Grind GuardBite Tech Inc. 510(k) NO: K150492(Traditional)ATTN: Jeff Padovan PHONE NO : 203 987689820 Glover Avenue SE DECISION MADE: 19-FEB-16Norwalk CT 06850 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mitePHADIA AB 510(k) NO: K150597(Traditional)ATTN: Carina Magnusson PHONE NO : 46 18 165000RAPSGATAN 7P SE DECISION MADE: 29-FEB-16UPPSALA SE 75137 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Nutra Face Lift Model PE8050NUTRA LUXE MD, LLC 510(k) NO: K150826(Traditional)ATTN: PETER VON BERG PHONE NO : 1 877 24104596835 INTERNATIONAL CENTER BLVD UNISE DECISION MADE: 10-FEB-16FORT MYERS FL 33912 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsCAREFUSION 2200 INC. 510(k) NO: K151036(Traditional)ATTN: JANE WEBER PHONE NO : 847 362809472 N. FAIRWAY DRIVE SE DECISION MADE: 01-FEB-16VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleSPECTRA MEDICAL DEVICES, INC. 510(k) NO: K151069(Traditional)ATTN: Agustin Turriza PHONE NO : 757 2208917260 F/H Fordham Road SE DECISION MADE: 05-FEB-16WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arthrex Short Suture AnchorsArthrex, Inc. 510(k) NO: K151092(Traditional)ATTN: David L Rogers PHONE NO : 239 6435553 719241370 Creekside Boulevard SE DECISION MADE: 23-FEB-16Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAESCULAP, INC. 510(k) NO: K151165(Traditional)ATTN: KATHY A. RACOSKY PHONE NO : 610 98492913773 CORPORATE PARKWAY SE DECISION MADE: 17-FEB-16CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)ABL Medical, LLC 510(k) NO: K151185(Traditional)ATTN: Robert Holladay PHONE NO : 801 7638000705 E 50 S SE DECISION MADE: 05-FEB-16American Fork UT 84003 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Nutrisafe 2- ENFit AdaptorVYGON 510(k) NO: K151237(Traditional)ATTN: Jillian Mikovich PHONE NO : 800 47354142750 MORRIS ROAD, SUITE A200 SE DECISION MADE: 09-FEB-16LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arm automatic blood pressure monitorSHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K151258(Special)ATTN: Xie Qiongyu PHONE NO : 086 0755 267107952/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 18-FEB-16NANSHAN DISTRICT, SHENZHEN, GUANGD510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Venturi Gauze Wound Care Sets with Portal DrainTALLEY GROUP LTD. 510(k) NO: K151263(Traditional)ATTN: ROBERT MACDONALD PHONE NO : 44 1794 503575PREMIER WAY, ABBEY PARK INDUSTRIALSE DECISION MADE: 19-FEB-16ROMSEY GB SO51 9DQ 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dr’s FinderGOOD DOCTORS CO., LTD. 510(k) NO: K151274(Traditional)ATTN: Sungro Joo PHONE NO : 82 32 4246325#208, Woolim Lions Valley B-dong, SE DECISION MADE: 04-FEB-16Incheon KR 403-911 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICONACY(TM) I-Hip (TM)ICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K151307(Traditional)ATTN: ROY Y HORI PHONE NO : 574 26946224130 CORRIDOR DRIVE SE DECISION MADE: 26-FEB-16WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSCHOELLY FIBEROPTIC, GMBH 510(k) NO: K151308(Traditional)ATTN: SANDRA BAUMANN PHONE NO : 49 7666 9080ROBERT-BOSCH-STR. 1-3 SE DECISION MADE: 09-FEB-16DENZLINGEN DE 79211 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Safe Block Pen NeedleArtsana S.P.A 510(k) NO: K151311(Abbreviated)ATTN: Cassani Mauro PHONE NO :Via Saldarini Catelli 1 SE DECISION MADE: 10-FEB-16Grandate IT 22070 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: StrialiteCentre Light Solutions, LLC 510(k) NO: K151337(Traditional)ATTN: Carrie Colburn PHONE NO : 574 6123381611 East Douglas Rd. Suite 108 SE DECISION MADE: 24-FEB-16Mishawaka IN 46545 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ProTrach DualcareATOS MEDICAL AB 510(k) NO: K151404(Traditional)ATTN: Ferenc Dahner PHONE NO : 46 415 19800KRAFTGATAN 8 SE DECISION MADE: 12-FEB-16HORBY SE SE-242 22 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Cogent Lateral Interbody SystemCOGENT SPINE LLC 510(k) NO: K151406(Traditional)ATTN: JUDE PAGANELLI PHONE NO : 858 7747897101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 25-FEB-16SOLANA BEACH CA 92075 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX Compounding System Transfer SetB. BRAUN MEDICAL INC. 510(k) NO: K151423(Traditional)ATTN: TRACY MADDOCK PHONE NO : 610 5962545901 MARCON BLVD. SE DECISION MADE: 19-FEB-16ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsINOVA DIAGNOSTICS, INC. 510(k) NO: K151429(Traditional)ATTN: GABRIELLA LAKOS PHONE NO : 858 5869900 13939900 OLD GROVE ROAD SE DECISION MADE: 12-FEB-16SAN DIEGO CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRCATPHILIPS MEDICAL SYSTEMS MR FINLAND510(k) NO: K151435(Traditional)ATTN: JANNE MARVOLA PHONE NO : 358 9 615800AYRITIE 4 SE DECISION MADE: 25-FEB-16VANTAA FI 01510 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ISUSDENTSPLY INTERNATIONAL, INC. 510(k) NO: K151439(Traditional)ATTN: HELEN LEWIS PHONE NO : 717 4871332221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 19-FEB-16YORK PA 17401 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K151474(Traditional)ATTN: MARY MOORE PHONE NO : 973 686249810 HIGH POINT DRIVE SE DECISION MADE: 18-FEB-16WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EndoChoice Select Injection NeedleENDOCHOICE, INC. 510(k) NO: K151475(Traditional)ATTN: THERON GOBER PHONE NO : 1 678 708442011810 WILLS RD. SE DECISION MADE: 08-FEB-16ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Beactive BraceNATURES PILLOWS, INC. 510(k) NO: K151476(Traditional)ATTN: WILLIAM McALISTER PHONE NO : 215 633 98012607 INTERPLEX DRIVE SE DECISION MADE: 26-FEB-16TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Epix Electrosurgical Probe with Smoke EvacuationAPPLIED MEDICAL RESOURCES 510(k) NO: K151480(Traditional)ATTN: FRANS VANDENBROEK PHONE NO : 949 713836922872 Avenida Empresa SE DECISION MADE: 19-FEB-16Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BCR-30-min BI? and RBIP-ST30? Readout AccessoryBCR DIAGNOSTICS, INC. 510(k) NO: K151482(Traditional)ATTN: BORIS ROTMAN PHONE NO : 480 80961561123 E. THUNDERHILL PL. SE DECISION MADE: 26-FEB-16PHOENIX AZ 85048 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IRENE Locking Compression Plate SystemTIANJIN ZHENGTIAN MEDICAL INSTRUME510(k) NO: K151508(Traditional)ATTN: YIFAN FU PHONE NO : 0086 10 82292929NO.318, JINGYI ROAD, AIRPORT ECONOSE DECISION MADE: 25-FEB-16TIANJIN CN 300308 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Star 60SKANRAY TECHNOLOGIES PRIVATE LIMIT510(k) NO: K151512(Traditional)ATTN: MAHADEVAN J PHONE NO : 91 821 2415559 501PLOT #360, KIADB INDUSTRIAL AREA, SE DECISION MADE: 14-FEB-16MYSORE IN 570018 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Oscar 2SunTech Medical, Inc. 510(k) NO: K151520(Abbreviated)ATTN: Charles Setzer PHONE NO : 919 6542300507 Airport Blvd, Suite 117 SE DECISION MADE: 19-FEB-16Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone CalibratorSIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K151529(Traditional)ATTN: JULIE WARREN PHONE NO : 302 6318722500 GBC DR. P.O. BOX 6101 M/S 514SE DECISION MADE: 11-FEB-16NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Anterior Cervical Plate SystemOsteomed Implantes, LTDA 510(k) NO: K151553(Traditional)ATTN: J.D. WEBB PHONE NO : 19 3532 3411Washington Luiz Road, km 172, CondSE DECISION MADE: 10-FEB-16Rio Claro – SP BR 13501-600 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Tranberg CLS Laser FiberClinical Laserthermia Systems AB 510(k) NO: K151569(Traditional)ATTN: Lars Erik Eriksson PHONE NO : 46 461 52100Scheelevagen 2 SE DECISION MADE: 12-FEB-16Lund SE 22381 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D.N.E. External Fixation SystemDNE, LLC 510(k) NO: K151580(Special)ATTN: NICHOLAS RICCIONE PHONE NO : 610 44210172225 PARK PLACE SE DECISION MADE: 16-FEB-16SLATINGTON PA 18080 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CapsoCam (SV-1)CapsoVision, Inc. 510(k) NO: K151635(Traditional)ATTN: AZIMUN JAMAL PHONE NO : 408 624148818805 Cox Ave Suite 250 SE DECISION MADE: 09-FEB-16Saratoga CA 95070 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Masimo Root Vital Signs Monitoring System and AccessoriesMASIMO CORPORATION 510(k) NO: K151644(Traditional)ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297768352 DISCOVERY SE DECISION MADE: 12-FEB-16IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue ColorSUQIAN XINGYE GLOVE CO, LTD 510(k) NO: K151680(Traditional)ATTN: JIAN ZHONG-DENG PHONE NO : 86 527 82860533DONGWU ROAD, THE ECONOMIC DEVELOPMSE DECISION MADE: 12-FEB-16SUQIAN CITY CN 223800 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: twionAlber GmbH 510(k) NO: K151717(Traditional)ATTN: Bernd Engels PHONE NO : 490 7432 2006180Vor dem Weissen Stein 21 SE DECISION MADE: 23-FEB-16Albstadt DE D72461 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MedicVOD SystemOrpheus Medical Ltd. 510(k) NO: K151737(Traditional)ATTN: Asaf Omer PHONE NO : 972 4 6968800PO Box 15140 SE DECISION MADE: 25-FEB-16Haifa IL 31905 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THUNDERBEAT Open Fine JawOLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K151743(Traditional)ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 64226942951 ISHIKAWA-CHO SE DECISION MADE: 26-FEB-16HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Actreen Mini Intermittent Urinary CathetersB. BRAUN MEDICAL INC. 510(k) NO: K151772(Traditional)ATTN: SIERRA M. MERTZ PHONE NO : 1 610 2660500901 MARCON BLVD. SE DECISION MADE: 09-FEB-16ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: InMode RF SystemINMODE MD LTD. 510(k) NO: K151793(Traditional)ATTN: AHAVA STEIN PHONE NO : 972 4 9097470TABOR BUILDING, SHAAR YOKNEAM SE DECISION MADE: 19-FEB-16YOQNEAM ILLIT IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST-YS Caspofungin <=0.125 – >=8 ug/mLBIOMERIEUX INC 510(k) NO: K151817(Traditional)ATTN: KAREN RUSSELL PHONE NO : 314 7318639595 ANGLUM ROAD SE DECISION MADE: 18-FEB-16HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Vital Signs Patch SystemLIFEWATCH TECHNOLOGIES LTD. 510(k) NO: K151835(Special)ATTN: ASHER KASSEL PHONE NO : 1 972 894840002 PEKERIS ST. SE DECISION MADE: 05-FEB-16REHOVOT IL 7670202 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD BACTEC Peds Plus/F Culture Vials (plastic)BECTON DICKINSON AND COMPANY 510(k) NO: K151866(Traditional)ATTN: ASHANTI C. BROWN PHONE NO : 410 31647667 LOVETON CIRCLE, MC 694 SE DECISION MADE: 25-FEB-16SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR-FLOW handy 3.0 PLUSE.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K151912(Traditional)ATTN: Suzanne Fassio-Hardy PHONE NO : 41 2299 44700Rte de Champ-Colin 2 SE DECISION MADE: 03-FEB-16Nyon CH CH-1260 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoistBAUSCH & LOMB INCORPORATED 510(k) NO: K151918(Traditional)ATTN: Barbara Klube-Falso PHONE NO : 585 33885031400 North Goodman Street SE DECISION MADE: 11-FEB-16Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Triumph Resin DamDENALI CORPORATION 510(k) NO: K151945(Traditional)ATTN: JAN G. STANNARD PHONE NO : 1 781 8269190134 OLD WASHINGTON STREET SE DECISION MADE: 18-FEB-16HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YuGo SystemBIOGAMING LTD. 510(k) NO: K151955(Traditional)ATTN: RONIT HARPAZ PHONE NO : 972 5 47070792HAMGSHIMIM 20 SE DECISION MADE: 05-FEB-16PETACH TIKVA IL 4934829 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FS-PACSEC-WEB CO., LTD. 510(k) NO: K152034(Traditional)ATTN: KE-MIN JEN PHONE NO : 886 2 255047904F., NO.89, TAIYUAN RD., DATONG DISE DECISION MADE: 23-FEB-16TAIPEI CITY TW 103 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Vesocclude Polymer Ligating ClipVesocclude Medical, LLC 510(k) NO: K152082(Traditional)ATTN: Freddy Cannady PHONE NO : 919 20131427429 ACC BLVD Suite 101 SE DECISION MADE: 26-FEB-16Raleigh NC 27617 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Liquid CO2-2 (LCO2-2)RANDOX LABORATORIES LTD 510(k) NO: K152085(Traditional)ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 2894422413 227555 DIAMOND ROAD SE DECISION MADE: 24-FEB-16ARDMORE GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IV-eyeNovarix Limited 510(k) NO: K152088(Traditional)ATTN: JOHN SCOTT PHONE NO : 44 01235 828292The Core Business Centre, Milton HSE DECISION MADE: 24-FEB-16Abingdon GB OX13 6AB 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CorMatrix TykeCORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K152127(Traditional)ATTN: ANDREW M. GREEN PHONE NO : 470 51440191100 OLD ELLIS ROAD SE DECISION MADE: 04-FEB-16ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Recovery Cone Removal SystemC.R. Bard, Inc. 510(k) NO: K152136(Traditional)ATTN: Joni Creal PHONE NO : 480 63829061625 West Third Street SE DECISION MADE: 18-FEB-16Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: High Pressure Tanning LampsBLV Licht-und Vakuumtechnik GmbH 510(k) NO: K152141(Traditional)ATTN: Heinz-Jurgen Wesseling PHONE NO : 49 8094 906206Munchener Strasse 10 SE DECISION MADE: 25-FEB-16Steinhoring DE 85643 510(k) STATEMENT

DEVICE: Navik 3DAPN Health, LLC 510(k) NO: K152160(Traditional)ATTN: David Geddam PHONE NO : 1 844 27687134900 Hopyard Road, Suite 100 SE DECISION MADE: 23-FEB-16Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Love Liquid Personal LubricantThe Kama Sutra Company 510(k) NO: K152168(Traditional)ATTN: Marla Lee PHONE NO : 805 49574792151 Anchor Court SE DECISION MADE: 05-FEB-16Thousand Oaks CA 91320 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT SHBGBIOKIT, S.A. 510(k) NO: K152185(Traditional)ATTN: ANGELS ROMA PHONE NO : 34 938 609000CAN MALE, S/N SE DECISION MADE: 11-FEB-16LLICA D AMUNT ES 08186 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off ScrewsMERETE MEDICAL GMBH 510(k) NO: K152187(Traditional)ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 49 30 779980114ALT-LANKWITZ 102 SE DECISION MADE: 12-FEB-16BERLIN DE 12247 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Erchonia EVRLERCHONIA CORPORATION 510(k) NO: K152196(Traditional)ATTN: STEVEN SHANKS PHONE NO : 214 54422272021 COMMERCE DR SE DECISION MADE: 18-FEB-16MCKINNEY TX 75069 510(k) STATEMENT

DEVICE: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBOSTON SCIENTIFIC CORPORATION 510(k) NO: K152231(Traditional)ATTN: Nikki M Wahlberg PHONE NO : 763 4942381One Scimed Place SE DECISION MADE: 12-FEB-16Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: The Entasis Dual-Lead Sacroiliac ImplantCoreLink, LLC 510(k) NO: K152237(Traditional)ATTN: Dan Hoehn PHONE NO : 888 34978087606 Forsyth Blvd SE DECISION MADE: 04-FEB-16St.Louis MO 63105 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Powder Free Nitrile Patient Examination Gloves, Black colorSUQIAN XINGYE GLOVE CO,LTD 510(k) NO: K152271(Traditional)ATTN: JIAN ZHANG DENG PHONE NO : 86 527 82860533DONGWU ROAD,THE ECONOMIC DEVELOPMESE DECISION MADE: 09-FEB-16SUQIAN CITY CN 223800 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFLOW II – Irrigation, Warming and Suction SystemPROMEPLA SAM 510(k) NO: K152278(Traditional)ATTN: ALEXANDRE BAREILLE PHONE NO : 377 97 9842449 AVENUE ALBERT II SE DECISION MADE: 09-FEB-16MONACO MC 98000 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OBS Anchorage ScrewBOMEI CO., LTD 510(k) NO: K152297(Traditional)ATTN: LINNEY CHIANG PHONE NO : 886 3 35549894F., NO.1492-2, CHUNRIH RD., TAOYUSE DECISION MADE: 09-FEB-16TAOYUAN CITY TW 33051 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HeartLight Deflectable SheathCARDIOFOCUS, INC. 510(k) NO: K152310(Traditional)ATTN: Seema Paliwal PHONE NO : 508 6587208500 NICKERSON ROAD SUITE 500-200 SE DECISION MADE: 24-FEB-16MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YAHUA Spinal SystemBEIJING WEIGAO YAHUA ARTIFICIAL JO510(k) NO: K152324(Traditional)ATTN: XINJIAN LV PHONE NO : 86 10 69416956NO.7, NIUHUI STREET, NIULANSHAN TOSE DECISION MADE: 01-FEB-16BEIJING CN 101301 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Perfectio LED infrared deviceOMM IMPORTS INC DBA ZERO GRAVITY 510(k) NO: K152332(Traditional)ATTN: OHAD MENACHEM PHONE NO : 954 805488561945 S OCEAN DR APT 509 HALLANDLE SE DECISION MADE: 25-FEB-16HALLANDLE FL 33009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Direct BilirubinRANDOX LABORATORIES LIMITED 510(k) NO: K152343(Traditional)ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 289442241355 DIAMOND ROAD, CRUMLIN SE DECISION MADE: 16-FEB-16COUNTY ANTRIM GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Top Fine Pen NeedleMEDEXEL CO., LTD. 510(k) NO: K152410(Traditional)ATTN: CHA DONG IK PHONE NO : 82 32 6778004252, GEUMGWANGOSAN-RO, GUEMGWANG-MSE DECISION MADE: 02-FEB-16ANSEONG-SI KR 17535 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IndegoPARKER HANNIFIN CORPORATION 510(k) NO: K152416(Traditional)ATTN: ACHILLEAS DOROTHEOU PHONE NO : 216 89620441390 E. HIGHLAND ROAD SE DECISION MADE: 26-FEB-16MACEDONIA OH 44056 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREND? Free T4 Test SystemNANOENTEK USA INC 510(k) NO: K152422(Traditional)ATTN: JIMMY CHEN PHONE NO : 925 22501085627 STONERIDGE DRIVE SUITE 304 SE DECISION MADE: 17-FEB-16PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PC ECGEDAN INSTRUMENTS, INC. 510(k) NO: K152427(Traditional)ATTN: QUEENA CHEN PHONE NO : 86 755 268587363/F – B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 05-FEB-16SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETView VivaSight-SL (TVT) systemETVIEW LTD. 510(k) NO: K152438(Traditional)ATTN: YORAM LEVY PHONE NO : 972 72 2607063M.P MISGAV SE DECISION MADE: 25-FEB-16MISGAV BUSINESS PARK IL 201790 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Exofin High Viscosity Tissue AdhesiveCHEMENCE MEDICAL PRODUCTS INC. 510(k) NO: K152476(Abbreviated)ATTN: Kenneth Broadley PHONE NO : 770 2550493200 Technology Drive SE DECISION MADE: 09-FEB-16Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH Mini Ostial System – 3.0mm x 8mm x 135cm, FLASH Mini Ostial System – 3.5mm x 8mm x 135cm, FLASH Mini Ostial System – 4.0mm x 8mm x 135cm, FLASH Mini Ostial System – 4.5mm x 8mm x 135cmOSTIAL CORPORATION 510(k) NO: K152485(Traditional)ATTN: JAKE WOLENBERG PHONE NO : 408 54110061221 INNSBRUCK DRIVE SE DECISION MADE: 16-FEB-16SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPANORAMIC CORP. 510(k) NO: K152489(Traditional)ATTN: Doug Pack PHONE NO : 800 65420274321 Goshen Rd SE DECISION MADE: 04-FEB-16FT. WAYNE IN 46818 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPX 4 Breast Tissue ExpanderMENTOR WORLDWIDE LLC 510(k) NO: K152496(Traditional)ATTN: Manchi Cheung PHONE NO : 805 7082747201 MENTOR DRIVE SE DECISION MADE: 19-FEB-16SANTA BARBARA CA 93111 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C2 NerveMonitor SystemINOMED MEDIZINTECHNIK GMBH 510(k) NO: K152505(Traditional)ATTN: SASCHKA BUSCH PHONE NO : 49 7641 941487IM HAUSGRUEN 29 SE DECISION MADE: 01-FEB-16EMMENDINGEN BADEN- WUERTTEMBERG D510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NaturaLase CO2 Laser SystemFOCUS MEDICAL, LLC 510(k) NO: K152529(Abbreviated)ATTN: JOHN B LEE PHONE NO : 203 730888523 FRANCIS J CLARKE CIRCLE SE DECISION MADE: 04-FEB-16BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SpineView X-Pac Expandable Lumbar Cage SystemSPINE VIEW, INC. 510(k) NO: K152539(Traditional)ATTN: Mbithi Muthini PHONE NO : 510 623193148810 KATO ROAD SUITE 100E SE DECISION MADE: 24-FEB-16FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dental Implant SystemAriaBio International Inc 510(k) NO: K152555(Traditional)ATTN: Hagai Jacobsen PHONE NO :229 Overland Ave, Suite 118 SE DECISION MADE: 11-FEB-16Los Angeles CA 90064 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21 s.r.l. 510(k) NO: K152557(Traditional)ATTN: Maurizio Foroni PHONE NO : 39 0535 30312Via S. Pertini, 8 SE DECISION MADE: 23-FEB-16San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-VBRCARDINAL SPINE, LLC 510(k) NO: K152568(Traditional)ATTN: NATASHA LONNON PHONE NO : 502 777 478812307 OLD LAGRANGE ROAD, SUITE 105SE DECISION MADE: 11-FEB-16LOUISVILLE KY 40245 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DermaScalp Laser CapDERMASCALP LLC 510(k) NO: K152587(Traditional)ATTN: JOHN CARULLO PHONE NO : 214 68307241700 ALMA DR SUITE 400 SE DECISION MADE: 04-FEB-16PLANO TX 75075 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX EXAMINATION GLOVE POWDER FREECareplus (M) SDN BHD 510(k) NO: K152593(Traditional)ATTN: LIM KWEE SHYAN PHONE NO : 60 6 6772781Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 25-FEB-16SEREMBAN MY 70450 510(k) STATEMENT

DEVICE: Intact® Gen2 SystemINTACT MEDICAL CORPORATION 510(k) NO: K152596(Traditional)ATTN: JOHN VACHA PHONE NO : 508 6557820550 COCHITUATE RD SUITE 25 SE DECISION MADE: 15-FEB-16FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V20 systemVIORA LTD. 510(k) NO: K152611(Traditional)ATTN: OMRI KESLER PHONE NO : 972 9 95513443 MASKIT STREET SE DECISION MADE: 19-FEB-16HERZLIYA IL 4673303 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H3+ Holter RecorderMORTARA INSTRUMENT, INC 510(k) NO: K152626(Traditional)ATTN: Margaret Mucha PHONE NO : 414 35416007865 NORTH 86TH ST. SE DECISION MADE: 26-FEB-16MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Dictum HealthDICTUM HEALTH, INC 510(k) NO: K152645(Abbreviated)ATTN: PAUL LANDESMAN PHONE NO : 510 9003590255 3RD AVENUE, SUITE 102 SE DECISION MADE: 09-FEB-16OAKLAND CA 94607 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technolo510(k) NO: K152648(Traditional)ATTN: N/A N/A PHONE NO :Jinsigang Industrial Park, GuoxianSE DECISION MADE: 18-FEB-16Suzhou CN 215124 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDS Universal CementESSENTIAL DENTAL SYSTEMS, INC 510(k) NO: K152691(Traditional)ATTN: JEFFREY WAN PHONE NO : 201 487909089 LEUNING STREET, SUITE 8 SE DECISION MADE: 25-FEB-16SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)ENT BIOTECH SOLUTIONS 510(k) NO: K152702(Traditional)ATTN: LAURA YAMADA PHONE NO : 313 922461575 LEWISTON ROAD SE DECISION MADE: 18-FEB-16GROSS POINTE FARMS MI 48236 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLORHAINING MEDICAL PRODUCTS CO., LTD 510(k) NO: K152715(Traditional)ATTN: ZHANG LIANG PHONE NO : 86 315 4169201WEST OF DIANCHANG ROAD LUANNAN COUSE DECISION MADE: 25-FEB-16TANGSHAN CN 063500 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKIN CAREC.I.S LTD 510(k) NO: K152736(Traditional)ATTN: ILAN SHARON PHONE NO : 972 8 91545534 BEN GURION ST. SE DECISION MADE: 25-FEB-16NES ZIONA IL 7403201 510(k) STATEMENT

DEVICE: Electronic ThermometerGUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K152739(Traditional)ATTN: JING LIANG PHONE NO : 86 756 3399967INNOVATION FIRST ROAD, TECHNOLOGY SE DECISION MADE: 09-FEB-16ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)MICROLINE SURGICAL, INC. 510(k) NO: K152743(Traditional)ATTN: ANU GAUR PHONE NO : 978 867172650 DUNHAM ROAD SUITE 1500 SE DECISION MADE: 08-FEB-16BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEMB.BRAUN INTERVENTIONAL SYSTEMS INC510(k) NO: K152765(Traditional)ATTN: PETER FLOSDORF PHONE NO : 610 9974694824 TWELFTH AVENUE SE DECISION MADE: 26-FEB-16BETHLEHEM PA 18018 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripASSURE TECH. CO., LTD. 510(k) NO: K152768(Traditional)ATTN: ERIC LIN PHONE NO : 86 871 810226982ND. FLOOR, BUILDING 1, NO. 10, XISE DECISION MADE: 24-FEB-16HANGZHOU CN 310030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Adena-Zina SystemSHANGHAI SANYOU MEDICAL CO, LTD 510(k) NO: K152781(Traditional)ATTN: DAVID FAN PHONE NO : 86 21 583899801988 JIATANG ROAD SE DECISION MADE: 12-FEB-16JIADIANG DISTRICT CN 201807 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Amecath Peripheral inserted Central Venous Catheter SetsAMECO MEDICAL INDUSTRIES 510(k) NO: K152819(Traditional)ATTN: Samy Hamboly PHONE NO : 20 115 383066INDUSTRIAL AREA B4-PLOT #119 EAST SE DECISION MADE: 05-FEB-1610TH OF RAMADAN CITY EG 510(k) STATEMENT

DEVICE: Weely Manual WheelchairRupiani 510(k) NO: K152827(Traditional)ATTN: Jean-Marie Mangenot PHONE NO : 33 6645 517374 Avenue Du 8 Mai 1945 SE DECISION MADE: 19-FEB-16Vaudex En Velin FR 69120 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Spot SkanSKANRAY TECHNOLOGIES PRIVATE LIMIT510(k) NO: K152831(Traditional)ATTN: MAHADEVAN J PHONE NO : 91 821 2407202PLOT #360, KIADB INDUSTRIAL AREA, SE DECISION MADE: 23-FEB-16MYSORE IN 570018 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVIX-S 1012NVIEWORKS CO., LTD. 510(k) NO: K152855(Traditional)ATTN: YOONJAE IM PHONE NO : 82 70 70116176(GWANYANG-DONG) 41-3, BURIM-RO 170SE DECISION MADE: 26-FEB-16ANYANG-SI KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ExpressBraid Graft ManipulationBIOMET MANUFACTURING CORP. 510(k) NO: K152868(Traditional)ATTN: ADAM CARGILL PHONE NO : 574 371100656 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 08-FEB-16WARSAW IL 46581 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNTEC Mechanical Wheelchair, model ST-WL-1000DANYANG SUNTEC AUTO PARTS CO., LTD510(k) NO: K152878(Traditional)ATTN: JEN KE-MIN PHONE NO : 86 511 86380900JIEPAI INDUSTRIAL ZONE, JIEPAI, DASE DECISION MADE: 03-FEB-16ZHENJIANG CN 212300 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVIX-S 1717NVieworks Co., Ltd 510(k) NO: K152894(Traditional)ATTN: Yoonjae Im PHONE NO : 82 70 70116176(Gwanyang-dong) 41-3, Burim-ro 170SE DECISION MADE: 26-FEB-16Anyang-si KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIODE LASER THERAPY SYSTEMSBEIJING SINCOHEREN SCIENCE AND TEC510(k) NO: K152898(Traditional)ATTN: XIN WANG PHONE NO : 86 010 57734966ROOM 305, NO.43, XIZHIMEN NORTH STSE DECISION MADE: 09-FEB-16BEIJING CN 100044 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K152902(Traditional)ATTN: YANHONG BAI PHONE NO : 86 755 81885635MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 18-FEB-16SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ViziShot FLEXSPIRATION, INC. 510(k) NO: K152922(Traditional)ATTN: Cyndy J Adams PHONE NO : 425 63654506675 185th Ave NE SE DECISION MADE: 19-FEB-16REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BlastGenORIGIO A/S 510(k) NO: K152932(Traditional)ATTN: TOVE KJAER PHONE NO : 45 4679 0220KNARDRUPVEJ 2 SE DECISION MADE: 29-FEB-16MALOV DK 2760 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Medline Anti-Fog SolutionMedline Industries, Inc. 510(k) NO: K152948(Traditional)ATTN: Matt Clausen PHONE NO : 847 6434785One Medline Place SE DECISION MADE: 04-FEB-16Mundelein IL 60060 510(k) STATEMENT

DEVICE: Mammotome revolve Dual Vacuum Assist Biopsy SystemDEVICOR MEDICAL PRODUCTS, INC. 510(k) NO: K152989(Traditional)ATTN: SHAWNA M. ROSE PHONE NO : 513 8649178300 E-BUSINESS WAY, FIFTH FLOOR SE DECISION MADE: 25-FEB-16CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OptoWire DeuxOPSENS 510(k) NO: K152991(Traditional)ATTN: Vanessa Mootoosamy PHONE NO : 418 6829996 2392014, CYRILLE DUQUET STREET, #125 SE DECISION MADE: 11-FEB-16QUEBEC CA G1N 4N6 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AdaptivoAurora Technology Development, LLC510(k) NO: K152994(Traditional)ATTN: Gustavo H Olivera PHONE NO : 608 8315419555 D’Onofrio Dr., Suite 104 SE DECISION MADE: 03-FEB-16Madison WI 53719 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Clear Guide SCENERGYCLEAR GUIDE MEDICAL 510(k) NO: K153004(Traditional)ATTN: Jack Kent PHONE NO : 410 92977203600 Clipper Mill Road, Suite 400 SE DECISION MADE: 12-FEB-16Baltimore MD 21211 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZIBO HUIYING MEDICAL PRODUCTS, CO.510(k) NO: K153028(Traditional)ATTN: Fufang Wang PHONE NO : 86 189533 86552NO. 3 DA WU ROAD SE DECISION MADE: 05-FEB-16LINZI CN 255400 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N5-1NUGA MEDICAL CO., LTD 510(k) NO: K153054(Traditional)ATTN: JONG SOO LEE PHONE NO : 82 33 7300001185, JIRAEUL-RO, JIJEONG-MYEON SE DECISION MADE: 05-FEB-16Wonju KR 220-821 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HF1202H PowerPlus Portable X-ray EquipmentMINXRAY, INC. 510(k) NO: K153059(Special)ATTN: Keith Kretchmer PHONE NO : 847 56403233611 COMMERCIAL AVE. SE DECISION MADE: 02-FEB-16NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation for Sight 510(k) NO: K153066(Traditional)ATTN: Eugene Bonte PHONE NO : 781 7267503464 Hillside Avenue, Suite 205 SE DECISION MADE: 09-FEB-16Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure MonitorMICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K153077(Traditional)ATTN: GERHARD FRICK PHONE NO : 41 717 277000ESPENSTRASSE 139 SE DECISION MADE: 12-FEB-16WIDNAU CH 9443 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RTVue XR OCT Avanti with AngioVue SoftwareOPTOVUE, INC. 510(k) NO: K153080(Traditional)ATTN: EDWARD SINCLAIR PHONE NO : 510 89715752800 BAYVIEW DRIVE SE DECISION MADE: 11-FEB-16FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Clear Bi-LightMichael Todd, LP 510(k) NO: K153081(Traditional)ATTN: Lilia Friend PHONE NO : 772 3430222648 Port St Lucie Blvd SE DECISION MADE: 15-FEB-16Port St Lucie FL 34953 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Rampart A Lumbar Interbody Fusion DeviceSPINEOLOGY, INC. 510(k) NO: K153082(Traditional)ATTN: JACQUELINE A HAUGE PHONE NO : 651 25685007800 3RD STREET N, SUITE 600 SE DECISION MADE: 04-FEB-16ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLANT 3DMedia Lab S.r.l. 510(k) NO: K153091(Traditional)ATTN: Massimo Ivani PHONE NO : 39 018 7517775Via Trieste 4 SE DECISION MADE: 25-FEB-16Follo IT 19020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LL510(k) NO: K153095(Traditional)ATTN: Barry E Constantine PHONE NO : 732 831179716633 Dallas Parkway, Suite 250 SE DECISION MADE: 17-FEB-16Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESTREAM Vue PACSCARESTREAM HEALTH, INC. 510(k) NO: K153103(Traditional)ATTN: Diane Koetter PHONE NO : 585 6276505150 VERONA STREET SE DECISION MADE: 12-FEB-16ROCHESTER NY 14468 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SIGNS MONITORGUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K153135(Special)ATTN: Jin Liang PHONE NO : 86 756 3399967INNOVATION FIRST ROAD TECHNOLOGY ISE DECISION MADE: 25-FEB-16ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DyeVert Contrast Modulation SystemOSPREY MEDICAL, INC. 510(k) NO: K153141(Traditional)ATTN: MELANIE HESS PHONE NO : 952 95582525600 ROWLAND ROAD SUITE 250 SE DECISION MADE: 04-FEB-16MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIO-H DIGITAL RADIOGRAPHY SENSORDENTTIO, INC. 510(k) NO: K153144(Traditional)ATTN: YOUNG HAN PHONE NO : 323 25410003235 N. SAN FERNANDO ROAD BLDG 7B SE DECISION MADE: 10-FEB-16LOS ANGELES CA 90065 510(k) STATEMENT

DEVICE: MOR Implant SystemSTERNGOLD DENTAL, LLC 510(k) NO: K153173(Abbreviated)ATTN: MARIA RAO PHONE NO : 508 226566023 FRANK MOSSBERG DR SE DECISION MADE: 05-FEB-16ATTLEBORO MA 02703 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Calcium BridgeDENALI CORPORATION 510(k) NO: K153191(Traditional)ATTN: Jan G Stannard PHONE NO : 781 8269190134 OLD WASHINGTON STREET SE DECISION MADE: 26-FEB-16HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-PackKCI USA, INC. 510(k) NO: K153199(Traditional)ATTN: MARGARET MARSH PHONE NO : 210 25564816203 FARINON DRIVE SE DECISION MADE: 29-FEB-16SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Navigation InstrumentsGLOBUS MEDICAL INC. 510(k) NO: K153203(Traditional)ATTN: Kelly J Baker PHONE NO : 610 9301800 16702560 GENERAL ARMISTEAD AVENUE SE DECISION MADE: 03-FEB-16AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: In2Bones Kirschner wireIN2BONES SAS 510(k) NO: K153204(Traditional)ATTN: Morgane Grenier PHONE NO : 33 4 7229262628 CHEMIN DU PETIT BOIS SE DECISION MADE: 01-FEB-16ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M-Fix Acromioclavicular DeviceCORACOID SOLUTIONS, INC. 510(k) NO: K153211(Traditional)ATTN: STEVE GOLDEN PHONE NO : 650 740030615 NORMANS WAY SE DECISION MADE: 02-FEB-16PARK CITY UT 84060 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.510(k) NO: K153215(Traditional)ATTN: Keith Grafmeyer PHONE NO : 216 445340310000 Cedar Avenue SE DECISION MADE: 19-FEB-16Cleveland OH 44106 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Alpine Cemented Hip SystemORTHO DEVELOPMENT CORPORATION 510(k) NO: K153216(Traditional)ATTN: Drew Weaver PHONE NO : 801 619341912187 SOUTH BUSINESS PARK DRIVE SE DECISION MADE: 18-FEB-16DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arthrex Synergy UHD4 SystemARTHREX, INC. 510(k) NO: K153218(Traditional)ATTN: DAVID L ROGERS PHONE NO : 239 6435553 719241370 CREEKSIDE BOULEVARD SE DECISION MADE: 12-FEB-16NAPLES OH 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc510(k) NO: K153220(Traditional)ATTN: Kimberly Mangum PHONE NO : 610 448647740 Liberty Boulevard, Mail Code 65SE DECISION MADE: 19-FEB-16Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VitalStim(R) Plus Electrotherapy SystemDJO, LLC 510(k) NO: K153224(Traditional)ATTN: Natalia Shirina PHONE NO : 760 73455341430 DECISION STREET SE DECISION MADE: 17-FEB-16VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Cios SelectSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153232(Special)ATTN: PATRICIA D JONES PHONE NO : 610 448647440 LIBERTY BLVD 65-1A SE DECISION MADE: 10-FEB-16MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PTFE Super Sheath Introducer 2.1MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K153246(Special)ATTN: COURTNEY NIX PHONE NO : 215 25642011499 DELP DR. SE DECISION MADE: 12-FEB-16HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Fusion Compact Navigation SystemMEDTRONIC NAVIGATION, INC. 510(k) NO: K153247(Traditional)ATTN: RISHI SINHA PHONE NO : 269 9034373826 COAL CREEK CIRCLE SE DECISION MADE: 18-FEB-16LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Aingeal Activity SystemIntelesens, Ltd. 510(k) NO: K153275(Traditional)ATTN: Patricia Pepper PHONE NO : 440 28 9073680117 Heron Road SE DECISION MADE: 26-FEB-16Belfast GB BT3 9LE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TandemLung OxygenatorCARDIAC ASSIST, INC. 510(k) NO: K153295(Traditional)ATTN: GREG JOHNSON PHONE NO : 412 9637770 266240 ALPHA DR. SE DECISION MADE: 26-FEB-16PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. 510(k) NO: K153304(Traditional)ATTN: Marysa Loustalot PHONE NO : 650 4045824800 E Middlefield Road SE DECISION MADE: 01-FEB-16Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HS SutureTapeRIVERPOINT MEDICAL 510(k) NO: K153307(Special)ATTN: Edwin Anderson PHONE NO : 503 5178001825 NE 25th Avenue SE DECISION MADE: 12-FEB-16Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD Vacutainer UltraTouch Push Button Blood Collection SetBECTON, DICKINSON AND COMPANY 510(k) NO: K153309(Special)ATTN: Pasquale Amato PHONE NO : 201 84745131 BECTON DRIVE SE DECISION MADE: 12-FEB-16FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Palisade Pedicular Fixation SystemSPINEOLOGY, INC. 510(k) NO: K153323(Traditional)ATTN: JACQUELINE A HAUGE PHONE NO : 651 25685007800 3RD STREET NORTH SE DECISION MADE: 23-FEB-16SAINT PAUL MN 55128-5455 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care Inc. 510(k) NO: K153330(Traditional)ATTN: Arul Sterlin PHONE NO : 510 86443101360 South Loop Road SE DECISION MADE: 19-FEB-16Alameda CA 94202 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Epic Extremity Plate SystemEpic Extremity, LLC 510(k) NO: K153340(Traditional)ATTN: DAN SCHWARTZBAUER PHONE NO : 412 9560320120 Marguerite Dr, Ste 301 SE DECISION MADE: 09-FEB-16Cranberry Twp PA 16066 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Relieva Scout Multi-Sinus Dilation SystemACCLARENT, INC. 510(k) NO: K153341(Traditional)ATTN: JAMES PATRICK GARVEY PHONE NO : 650 68748071525-B O’BRIEN DRIVE SE DECISION MADE: 12-FEB-16MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Radiance V3GMV SOLUCIONES GLOBALES INTERNET S510(k) NO: K153368(Traditional)ATTN: CARLOS ILLANA PHONE NO : 34 918 072270CALLE DE ISAAC NEWTON, 11 SE DECISION MADE: 16-FEB-16MADRID ES 28760 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2M, Incorporated 510(k) NO: K153370(Traditional)ATTN: Nancy Giezen PHONE NO : 571 9192000751 Miller Drive SE SE DECISION MADE: 16-FEB-16Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation 510(k) NO: K153384(Traditional)ATTN: Rita Lee PHONE NO : 919 485835055 TW Alexander Drive, PO Box 1418SE DECISION MADE: 19-FEB-16Research Triangle Park NC 27709 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OS2-C Compression StapleIN2BONES SAS 510(k) NO: K153395(Traditional)ATTN: MORGANE GRENIER PHONE NO : 33 4 7229262628 CHEMIN DU PETIT BOIS SE DECISION MADE: 18-FEB-16ECULLY FR 63130 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Comprehensive SRS/Nexel ElbowBIOMET MANUFACTURING CORP. 510(k) NO: K153398(Traditional)ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 267663956 BELL DRIVE SE DECISION MADE: 03-FEB-16WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ArcScan Insight 100ARCSCAN, INC. 510(k) NO: K153416(Special)ATTN: Andy Levien PHONE NO : 773 3875548443 PARK POINT DR, SUITE 225 SE DECISION MADE: 02-FEB-16GOLDEN CO 80401 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE i7ALPINION MEDICAL SYSTEMS CO., LTD.510(k) NO: K153424(Traditional)ATTN: Donghwan KIM PHONE NO : 82 707 46520681FL and 6FL Verdi Tower, 72, DigitSE DECISION MADE: 26-FEB-16SEOUL KR 08393 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE SystemsMedtronic Sofamor Danek USA, Inc. 510(k) NO: K153442(Traditional)ATTN: Lila Joe PHONE NO : 901 39923091800 Pyramid Place SE DECISION MADE: 18-FEB-16Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI Astato XS 40ASAHI INTECC CO., LTD. 510(k) NO: K153443(Traditional)ATTN: YOSHIHIKO FUKUI PHONE NO : 81 527 6812111703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 25-FEB-16NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBIOCHEMICAL DIAGNOSTICS, INC 510(k) NO: K153474(Traditional)ATTN: ALLEN PANETZ PHONE NO : 631 5959200180 HEARTLAND BLVD SE DECISION MADE: 23-FEB-16EDGEWOOD NY 11717 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNINEPOINT MEDICAL, INC 510(k) NO: K153479(Traditional)ATTN: EMAN NAMATI PHONE NO : 617 250719012 OAK PARK DRIVE SE DECISION MADE: 16-FEB-16BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSARROW INTERNATIONAL, INC. (Subsidi510(k) NO: K153487(Special)ATTN: Elizabeth Duncan PHONE NO : 610 37801312400 BERNVILLE ROAD SE DECISION MADE: 04-FEB-16READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. 510(k) NO: K153488(Traditional)ATTN: Paul Joseph Fitzpatrick PHONE NO : 1 423 321896425 E. Main Street, Suite 205 SE DECISION MADE: 25-FEB-16Chattanooga TN 37408 510(k) STATEMENT

DEVICE: Cryocare CS Surgical SystemHealth Tronics 510(k) NO: K153489(Traditional)ATTN: Maritza Ward PHONE NO : 512 43983619825 Spectrum Dr. SE DECISION MADE: 05-FEB-16Austin TX 78717 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Stryker CMF MEDPOR Customized ImplantStryker 510(k) NO: K153508(Traditional)ATTN: Jonathan Schell PHONE NO : 269 3895596750 Trade Centre Way, Suite 200 SE DECISION MADE: 05-FEB-16Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSION Vascular GraftMAQUET CARDIOVASCULAR, LLC 510(k) NO: K153523(Traditional)ATTN: Mark Dinger PHONE NO : 973 709769145 BARBOUR POND DRIVE SE DECISION MADE: 16-FEB-16WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PacEndo EDTAPAC-DENT INTERNATIONAL, INC. 510(k) NO: K153528(Traditional)ATTN: Wenying Zhu PHONE NO : 909 8390888670 ENDEAVOR CIRCLE SE DECISION MADE: 01-FEB-16Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WS80A Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD. 510(k) NO: K153529(Third Party – Traditional)ATTN: Kyeong-Mi Park PHONE NO : 82 2 2194137342, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 02-FEB-16SEOUL KR 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW

DEVICE: Bridge Occlusion BalloonSPECTRANETICS, INC. 510(k) NO: K153530(Traditional)ATTN: Christopher McLellan PHONE NO : 719 44720009965 FEDERAL DRIVE SE DECISION MADE: 05-FEB-16COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WHILL Model MWHILL, INC. 510(k) NO: K153543(Third Party – Traditional)ATTN: TERESE BOGUCKI PHONE NO : 650 4887799285 OLD COUNTY RD, SUITE 6 SE DECISION MADE: 12-FEB-16SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW

DEVICE: VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMVISIONSENSE LTD 510(k) NO: K153548(Traditional)ATTN: ALEX CHANIN PHONE NO : 972 3 924433920 HAMAGSHIMIM ST SE DECISION MADE: 22-FEB-16PETACH TIKVA, HAMERKAZ IL 49348 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Axxent Electronic Brachytherapy System Model 110 XP 1200ICAD INC. 510(k) NO: K153570(Traditional)ATTN: John DeLucia PHONE NO : 603 546743098 SPITBROOK ROAD, SUITE 100 SE DECISION MADE: 25-FEB-16NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Tyber Medical Trauma ScrewTYBER MEDICAL LLC 510(k) NO: K153575(Traditional)ATTN: Mark F Schenk PHONE NO : 610 507825589 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 26-FEB-16MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Arthrex iBalance TKA SystemArthrex, Inc. 510(k) NO: K153586(Traditional)ATTN: Leon Brown PHONE NO : 239 6435553 720281370 Creekside Boulevard SE DECISION MADE: 19-FEB-16Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EndoChoice Water Bottle Cap SystemENDOCHOICE, INC. 510(k) NO: K153588(Special)ATTN: Daniel Hoefer PHONE NO : 678 708474311810 WILLS RD. SE DECISION MADE: 24-FEB-16ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K153589(Traditional)ATTN: ANKIT K. SHAH PHONE NO : 901 39631331800 PYRAMID PLACE SE DECISION MADE: 10-FEB-16MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CliniscanSM MRIPICOFEMTO LLC 510(k) NO: K153593(Traditional)ATTN: Jessica Phillips PHONE NO : 646 8283612228 EAST 45TH STREET SE DECISION MADE: 17-FEB-16NEW YORK NY 10017 510(k) STATEMENT

DEVICE: ivWatch Model 400ivWatch, LLC 510(k) NO: K153605(Special)ATTN: Jaclyn Lautz PHONE NO : 855 4892824 7023469 McLaws Circle SE DECISION MADE: 11-FEB-16Williamsburg VA 23185 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Vitoss BiModal Bone Graft Substitute Foam StripORTHOVITA, INC. 510(k) NO: K153608(Special)ATTN: LYNN LUNDY PHONE NO : 1 610 407525645 GREAT VALLEY PARKWAY SE DECISION MADE: 12-FEB-16MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)BOSTON SCIENTIFIC CORPORATION 510(k) NO: K153617(Special)ATTN: Eric Elliott PHONE NO : 510 624131447215 LAKEVIEW BLVD SE DECISION MADE: 25-FEB-16FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Single Use Injector NM600/610OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K153625(Traditional)ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 64226942951 ISHIKAWA-CHO SE DECISION MADE: 12-FEB-16HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc 510(k) NO: K153631(Special)ATTN: Ted Kuhn PHONE NO : 303 50185497375 Bush Lake Road SE DECISION MADE: 16-FEB-16Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TSolution One w/ACG+ Surgical SystemTHINK SURGICAL INC. 510(k) NO: K153647(Traditional)ATTN: IN K. MUN PHONE NO : 510 249230047320 MISSION FALLS COURT SE DECISION MADE: 16-FEB-16FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: The Cellfina SystemULTHERA, INC. 510(k) NO: K153677(Special)ATTN: Suzon Lommel PHONE NO : 408 64549791840 S Stapley Dr, Suite 200 SE DECISION MADE: 25-FEB-16Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PriMatrix Dermal Repair ScaffoldTEI BioSciences Inc. 510(k) NO: K153690(Traditional)ATTN: David D Cox PHONE NO : 617 26816167 Elkins Street SE DECISION MADE: 22-FEB-16Boston MD 02127 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Spirit Hair Removal laser FamilyACTIVE OPTICAL SYSTEMS , LTD. 510(k) NO: K153718(Third Party – Traditional)ATTN: GIL Bidas PHONE NO : 972 3 923661011 SHOHAM ST. SE DECISION MADE: 12-FEB-16PETACH-TIKVA IL 49591 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW

DEVICE: SIGN Compression Screw SystemSIGN FRACTURE CARE INTERNATIONAL 510(k) NO: K153759(Traditional)ATTN: ROB R. TEETER PHONE NO : 509 3711107451 Hills Street, Suite B SE DECISION MADE: 25-FEB-16Richland WA 99354 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TraumaCad Mobile Release 2.0Voyant Health Ltd 510(k) NO: K160001(Special)ATTN: Yael Guttentag PHONE NO : 972 392 9092935 Efal Street SE DECISION MADE: 12-FEB-16Petach-Tikva IL 4951132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Sniper (R) Spine SystemSPINE WAVE, INC. 510(k) NO: K160003(Traditional)ATTN: KELLY Barbieri PHONE NO : 203 94494943 ENTERPRISE DRIVE SUITE 210 SE DECISION MADE: 26-FEB-16SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: iHealth Track Blood Pressure MonitorAndon Health Co., Ltd 510(k) NO: K160014(Special)ATTN: Liu Yi PHONE NO : 86 22 60526161 8060No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 02-FEB-16Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Image1 SPIES SystemKARL STORZ ENDOSCOPY AMERICA, INC.510(k) NO: K160044(Special)ATTN: SUSIE S. CHEN PHONE NO : 424 21882012151 E. GRAND AVE SE DECISION MADE: 01-FEB-16EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: McLaren Proton Therapy SystemMcLaren Health Care Corporation 510(k) NO: K160063(Traditional)ATTN: Ryan Vlcko PHONE NO : 810 3421174G-3235 Beecher Rd., Suite B SE DECISION MADE: 25-FEB-16Flint MI 48532 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FilmArray Respiratory Panel (RP) for use with FilmArray TorchBioFire Diagnostics, LLC 510(k) NO: K160068(Special)ATTN: KRISTEN J. KANACK PHONE NO : 801 7366354 330390 Wakara Way SE DECISION MADE: 08-FEB-16Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Digital ElectrocardiographSHENZHEN BIOCARE BIO-MEDICAL EQUIP510(k) NO: K160092(Special)ATTN: Hongbo Zhong PHONE NO : 86 755 36615333#A735,Shenzhen Mingyou Industrial SE DECISION MADE: 12-FEB-16Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: InZone Detachment SystemSTRYKER NEUROVASCULAR 510(k) NO: K160096(Special)ATTN: KATE TAYLOR PHONE NO : 510 413217547900 BAYSIDE PARKWAY SE DECISION MADE: 19-FEB-16FREMONT CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Synapse PACSFUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K160108(Traditional)ATTN: Jyh-Shyan Lin PHONE NO : 301 2511092419 WEST AVENUE SE DECISION MADE: 03-FEB-16STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK hsE2 Calibrator SetTOSOH BIOSCIENCE, INC. 510(k) NO: K160113(Traditional)ATTN: ROBERT L WICK PHONE NO : 650 63681176000 SHORELINE COURT SUITE 101 SE DECISION MADE: 17-FEB-16SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & Co. 510(k) NO: K160161(Special)ATTN: Gregory P. Payne PHONE NO : 858 795789010865 Road to the Cure, Suite 200 SE DECISION MADE: 24-FEB-16San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & Co. 510(k) NO: K160164(Special)ATTN: Gregory P. Payne PHONE NO : 858 795789010865 Road to the Cure, Suite 200 SE DECISION MADE: 25-FEB-16San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Illuminated Mediastinal Access PortAegis Surgical Ltd 510(k) NO: K160171(Special)ATTN: William Starling PHONE NO : 919 25197554020 Stirrup Creek Drive Suite 115SE DECISION MADE: 26-FEB-16Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific Corporation 510(k) NO: K160173(Special)ATTN: Eric Elliott PHONE NO : 510 624131447215 Lakeview Boulevard SE DECISION MADE: 26-FEB-16Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ S7 ExpertGE Healthcare 510(k) NO: K160182(Special)ATTN: Bryan Behn PHONE NO : 414 72142149900 Innovation Dr. SE DECISION MADE: 26-FEB-16Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Voluson S6, Voluson S8, Voluson S10GE HEALTHCARE 510(k) NO: K160184(Traditional)ATTN: TRACEY ORTIZ PHONE NO : 262 67661209900 W. INNOVATION DRIVE SE DECISION MADE: 25-FEB-16WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Fujifilm Video Colonoscope Model EC-600WL V2FUJIFILM Medical Systems U.S.A., I510(k) NO: K160196(Special)ATTN: Shraddha More PHONE NO : 973 686262710 High Point Drive SE DECISION MADE: 23-FEB-16Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UreTron MultiProbe Lithotripter SystemMed-Sonics Corp 510(k) NO: K160198(Special)ATTN: Jennifer Rautine PHONE NO : 814 89965004960 Pittsburgh Avenue Suite A SE DECISION MADE: 23-FEB-16Erie PA 16509 510(k) STATEMENT

DEVICE: 2MP Color LCD Monitor, RadiForce RX250 and RX250-AREIZO Corporation 510(k) NO: K160247(Traditional)ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468153 Shimokashiwano SE DECISION MADE: 23-FEB-16Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Optimus ALIF SystemAmendia, Inc. 510(k) NO: K160291(Special)ATTN: Kristen Allen PHONE NO : 877 75533291755 West Oak Parkway SE DECISION MADE: 18-FEB-16Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I4 (Integrated Intelligent Imaging Informatics) systemPHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K160315(Third Party – Traditional)ATTN: Ilana Ben Moshe PHONE NO : 972 525 233496VEENPLUIS 4-6 SE DECISION MADE: 19-FEB-16BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEW

DEVICE: syngo.via MI WorkflowsSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K160317(Special)ATTN: Veronica Padharia PHONE NO : 630 87757612501 N. BARRINGTON RD SE DECISION MADE: 29-FEB-16Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)JVC KENWOOD Corporation 510(k) NO: K160326(Traditional)ATTN: Tsukasa Tashiro PHONE NO : 81 258 2466113-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 23-FEB-16Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIVA ZSP2105CMI with QUBYX PerfectLum bundleTHE LINDEN GROUP CORP. 510(k) NO: K160328(Traditional)ATTN: ROBERT COLAIZZO PHONE NO : 973 98388092B WING DR SE DECISION MADE: 25-FEB-16CEDAR KNOLLS NJ 079271020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Novilase Laser Therapy System, Model LTS-2NOVIAN HEALTH, INC. 510(k) NO: K160392(Special)ATTN: WILLIAM GRAVEMAN PHONE NO : 312 2667200430 W. ERIE ST., SUITE 500 SE DECISION MADE: 26-FEB-16CHICAGO IL 60654 510(k) SUMMARY AVAILABLE FROM FDA

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA