Medical Devices

October 2016 510(k) Clearances

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


DEVICE: EasyMap MAP Catheter
MedFact Engineering GmbH          510(k) NO: K151139(Traditional)
ATTN: Joerg  Reinhardt            PHONE NO : 49 7621 579820 
Hammerstr.3                       SE DECISION MADE: 18-OCT-16
Loerrach, Baden-Wurttemberg  DE D-510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
SCHUTZ DENTAL GMBH                510(k) NO: K151399(Traditional)
ATTN: ANTJE  MAURER               PHONE NO : 49 0 60038140 
DIESELSTRASSE 5-6                 SE DECISION MADE: 24-OCT-16
ROSBACH  DE DE 61191              510(k) STATEMENT
                                                    

DEVICE: KJ Mini Implant System
KJ MEDITECH CO., LTD.             510(k) NO: K151970(Traditional)
ATTN: GOONG-SAN  NAM              PHONE NO : 82 62 9725476 
959-21 DAECHON-DONG, BUK-GU       SE DECISION MADE: 21-OCT-16
GWANG-JU  KR 959-21               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Painmaster MCT Patch
NEWMARK, INC.                     510(k) NO: K151995(Traditional)
ATTN: Francis  Powell             PHONE NO : 
131 Quarry Road                   SE DECISION MADE: 05-OCT-16
Cheshire CT  06410                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Pressure Transducer
ZHEJIANG HAISHENG MEDICAL DEVICE C510(k) NO: K152472(Traditional)
ATTN: Junbin  Hu                  PHONE NO : 86 575 88158510 
305#TANGGONG ROAD, PAOJIANG INDUSTSE DECISION MADE: 31-OCT-16
SHAOXING  CN 312071               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xonrid Gel
Helsinn Healthcare SA             510(k) NO: K152533(Traditional)
ATTN: Valentina  Tombolini Bossi  PHONE NO : 41 919 852121 
Via Pain Scairolo 9               SE DECISION MADE: 28-OCT-16
Lugano  CH 6912                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Respiratory Panel EZ (RP EZ)
BIOFIRE DIAGNOSTICS, LLC          510(k) NO: K152579(Dual Track)
ATTN: KRISTEN J. KANACK           PHONE NO : 801 7366354 330
390 WAKARA WAY                    SE DECISION MADE: 03-OCT-16
SALT LAKE CITY UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynarex Xeroform Petrolatum Dressing
DYNAREX CORPORATION               510(k) NO: K152970(Traditional)
ATTN: JAMES   HURLMAN             PHONE NO : 845 3658200 
10 GLENSHAW STREET                SE DECISION MADE: 03-OCT-16
ORANGEBURG NY  10962              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aoni Natural Rubber Latex Condom
Guangzhou Daming United Rubber Pro510(k) NO: K153016(Abbreviated)
ATTN: Yongbing  Xie               PHONE NO : 86 202268 08888687 
NO. 1 Daming Street, Port IndustriSE DECISION MADE: 20-OCT-16
Guangzhou  CN 510802              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caremed patient cable and leadwires
SHENZHEN CAREMED MEDICAL TECHNOLOG510(k) NO: K153188(Traditional)
ATTN: XINLIN  XIAO                PHONE NO : 86 755 2714369 
ZONE B, 3/F, 11 BUILDING, HEBEI INSE DECISION MADE: 24-OCT-16
SHENZHEN  CN 518021               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETIII SA Fixture System (O3.2mm)
HIOSSEN INC.                      510(k) NO: K153332(Traditional)
ATTN: PATRICK   LIM               PHONE NO : 888 6780001 
85 BEN FAIRLESS DR.               SE DECISION MADE: 27-OCT-16
FAIRLESS HILLS PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IH Implant System
Sewon Medix Inc.                  510(k) NO: K153521(Traditional)
ATTN: Bum-keun  Park              PHONE NO : 82 51 3031713 
#29, Sa-sang-ro, 375beon-gil, Sa-sSE DECISION MADE: 14-OCT-16
Busan  KR 46946                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS80A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD.         510(k) NO: K153539(Traditional)
ATTN: Kyeong-Mi  Park             PHONE NO : 82 2 21941373 
42, TEHERAN-RO 108-GIL,  GANGNAM-GSE DECISION MADE: 03-OCT-16
SEOUL  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FTRD System Set
OVESCO ENDOSCOPY AG               510(k) NO: K153550(Traditional)
ATTN: MARC O. SCHURR              PHONE NO : 49 7071 98979121 
DORFACKERSTRASSE 26               SE DECISION MADE: 12-OCT-16
TUEBINGEN  DE 72074               510(k) STATEMENT
                                                    

DEVICE: FREND Testosterone Test System
NanoEnTek USA Inc.                510(k) NO: K153577(Traditional)
ATTN: Jimmy  Chen                 PHONE NO : 925 2250108 
5627 Stoneridge Drive Suite 304   SE DECISION MADE: 14-OCT-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunmed Haemostatic Valves
SUNNY MEDICAL DEVICE (SHENZHEN) CO510(k) NO: K153685(Traditional)
ATTN: James  Qi  Zhang            PHONE NO : 949 2168838 
56 LEHIGH AISLE                   SE DECISION MADE: 13-OCT-16
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Volumetric Infusion Controller
DEKA RESEARCH & DEVELOPMENT       510(k) NO: K153760(Traditional)
ATTN: Julie   Perkins             PHONE NO : 603 6695139 
340 COMMERCIAL ST.                SE DECISION MADE: 03-OCT-16
MANCHESTER NH  03101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R:GEN Laser System
Lutronic Corporation              510(k) NO: K153769(Traditional)
ATTN: Jhung Won Vojir             PHONE NO : 82 31 9083440 
219, Sowon-ro, Deogyang-gu        SE DECISION MADE: 05-OCT-16
Goyang-si  KR 410-220             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOSOGARD FILTERS
Evoqua Water Technologies, LLC    510(k) NO: K153784(Traditional)
ATTN: Robert  Dudek               PHONE NO : 978 6147359 
10 Technology Drive               SE DECISION MADE: 21-OCT-16
Lowell MA  01851                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DMi Dental Implant System
DMi Innovative Medical Technology 510(k) NO: K160060(Traditional)
ATTN: Yaniv Haim Buchacho         PHONE NO : 972 3 6225879 
84 Sokolov St,                    SE DECISION MADE: 03-OCT-16
Holon  IL 58330                   510(k) STATEMENT
                                                    

DEVICE: AUTION ELEVEN Semi-Automated Urinalysis System
ARKRAY, Inc.                      510(k) NO: K160062(Traditional)
ATTN: Tom  Speikers (U.S. Agent)  PHONE NO : 81 75 6628979 
Yousuien-Nai, 59 Gansuin-Cho      SE DECISION MADE: 07-OCT-16
Kamigyo-Ku  JP 602-0008           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart D Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K160074(Traditional)
ATTN: Karen  Roche                PHONE NO : 651 2568500 
7800 Third Street North, Suite 600SE DECISION MADE: 18-OCT-16
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XCage™ Interbody Fusion System
Ouroboros Medical, Inc.           510(k) NO: K160076(Traditional)
ATTN: John  To                    PHONE NO : 510 9333456 
47757 Fremont Blvd                SE DECISION MADE: 13-OCT-16
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS Electrodes
CATHAY MANAFACTURING CORP.        510(k) NO: K160081(Traditional)
ATTN: Ren  Ren                    PHONE NO : 86 21 57878328 
No. 328, Xishe Road, Maogang Town,SE DECISION MADE: 19-OCT-16
Shanghai  CN 201607               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prestige Ameritech Pediatric/Child’s Face mask
Prestige Ameritech                510(k) NO: K160100(Traditional)
ATTN: RODNEY  GREGORY             PHONE NO : 817 4272700 
7201 Iron Horse Blvd.             SE DECISION MADE: 07-OCT-16
North Richland Hills TX  76180    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spetzler Malis Dual Illuminating Bipolar Forceps
SYNERGETICS                       510(k) NO: K160103(Traditional)
ATTN: DAN  REGAN                  PHONE NO : 636 7945013 
3845 CORPORATE CENTRE DRIVE       SE DECISION MADE: 12-OCT-16
O' FALLON MO  63368               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpiroScout
GANSHORN MEDIZIN ELECTRONIC GMBH  510(k) NO: K160116(Traditional)
ATTN: Stefan  Ponto               PHONE NO : 49 977 1622240 
INDUSTRIESTR 6-8                  SE DECISION MADE: 07-OCT-16
Niederlauer  DE 97618             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorPath GRX System
Corindus, Inc.                    510(k) NO: K160121(Traditional)
ATTN: Michael  Douglas            PHONE NO : 508 6533335 
309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 27-OCT-16
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: miraDry System
Miramar Labs, Inc.                510(k) NO: K160141(Traditional)
ATTN: Kathy  O'Shaughnessy        PHONE NO : 408 9408700 
2790 Walsh Avenue                 SE DECISION MADE: 31-OCT-16
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearVision ExamVue Flat Panel Detector
JPI HEALTHCARE, INC               510(k) NO: K160143(Traditional)
ATTN: JANG WON LEE                PHONE NO : 82 31 4913435 100
WOOLIM E-BIZ CENTER #608, 170-5   SE DECISION MADE: 28-OCT-16
KURO 3-DONG, KURO-GU  KR 152-769  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I.B.S. 2.0 Osteosynthesis screw
In2Bones SAS                      510(k) NO: K160174(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 33 472 292626 
28 chemin du Petit Bois           SE DECISION MADE: 06-OCT-16
ECULLY  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COLORADO THERAPEUTICS XENOGRAFT IMPLANT
Colorado Therapeutics LLC         510(k) NO: K160181(Traditional)
ATTN: WILLIAM  JACKSON            PHONE NO : 303 4699459 
2150 WEST 6TH AVENUE SUITE L      SE DECISION MADE: 20-OCT-16
BROOMFIELD CO  80020              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnSite Velocity Surface Electrode Kit
ST. JUDE MEDICAL                  510(k) NO: K160186(Traditional)
ATTN: YUMI  WACKERFUSS            PHONE NO : 651 7562675 
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 07-OCT-16
ST.PAUL MN  55117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
ST. JUDE MEDICAL                  510(k) NO: K160187(Traditional)
ATTN: MELISSA  FRANK              PHONE NO : 651 7562954 
ONE ST. JUDE MEDICAL              SE DECISION MADE: 21-OCT-16
ST. PAUL MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advocate Insulin Pen Needles
Diabetic Supply of Suncoast, Inc. 510(k) NO: K160199(Traditional)
ATTN: Victoria  Thuss             PHONE NO : 787 2706300 
Bo.Espinosa Carr.2km.26.2         SE DECISION MADE: 19-OCT-16
Dorado PR  00646-9532             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAMANT ZIRCONIA DISC
Adamant Co., Ltd.                 510(k) NO: K160203(Traditional)
ATTN: Deborah Lavoie Grayeski     PHONE NO : 81 3 39191171 
1-16-7 Shinden, Adachi Ku         SE DECISION MADE: 19-OCT-16
Tokyo  JP 123-8595                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uVue HSG/SHG Catheter
COOK INCORPORATED                 510(k) NO: K160217(Traditional)
ATTN: Kara  Kanorr                PHONE NO : 812 3392235 104072
750 DANIELS WAY                   SE DECISION MADE: 06-OCT-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visco (olifilcon A) soft contact lens
Visco Vision Inc                  510(k) NO: K160245(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 24-OCT-16
Taoyuan  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimulCare II(TM)
XANACARE TECHNOLOGIES, LLC        510(k) NO: K160246(Traditional)
ATTN: THOMAS C SIIROLA            PHONE NO : 720 5549262 
9185 EAST KENYON AVENUE # 270     SE DECISION MADE: 06-OCT-16
DENVER CO  80237-1857             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempo Temporary Pacing Lead
BIO TRACE MEDICAL, INC.           510(k) NO: K160260(Traditional)
ATTN: Laura  N.  Dietch           PHONE NO : 650 7794742 
831 BRANSTEN RD, SUITE L          SE DECISION MADE: 25-OCT-16
SAN CARLOS CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter MD300CG11/MD300CG51
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K160268(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD BADACHU HI-TESE DECISION MADE: 14-OCT-16
BEIJING  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANYVIEW-500R Fluoroscopic Mobile X-Ray System
ECOTRON CO.,LTD                   510(k) NO: K160279(Traditional)
ATTN: Sang  Bong  Lee             PHONE NO : 82 2 20253760 
RM 504, HANSHIN IT TOWER II, 47, DSE DECISION MADE: 14-OCT-16
SEOUL  KR 153-712                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
PAJUNK GMBH MEDIZINTECHNOLOGIE    510(k) NO: K160294(Traditional)
ATTN: CHRISTIAN G.H. QUASS        PHONE NO : 49 077 049291586 
KARL-HALL STR. 1                  SE DECISION MADE: 21-OCT-16
GEISINGEN  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPROTTE NRFit, Quincke NRFit
PAJUNK GmbH Medizintechnologie    510(k) NO: K160295(Traditional)
ATTN: Christian G. H. Quass       PHONE NO : 49 0770 49291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 27-OCT-16
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPROTTE SPECIAL NRFit
PAJUNK GMBH MEDIZINTECHNOLOGIE    510(k) NO: K160296(Traditional)
ATTN: CHRISTIAN G.H. QUASS        PHONE NO : 49 077 049291586 
KARL-HALL STR. 1                  SE DECISION MADE: 27-OCT-16
GEISINGEN  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tuohy NRFit
PAJUNK GmbH Medizintechnologie    510(k) NO: K160297(Traditional)
ATTN: Christian G.H. Quass        PHONE NO : 49 077 049291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 28-OCT-16
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FRAXIS DUO 
ILOODA CO., LTD                   510(k) NO: K160312(Traditional)
ATTN: YUN JUNG HA                 PHONE NO : 82 263 662124 
120, JANGAN-RO 458 BEON-GIL JANGANSE DECISION MADE: 28-OCT-16
SUWON-SI  KR 100-85816200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xenco Medical Cervical Interbody System
XENCO MEDICAL, LLC                510(k) NO: K160313(Traditional)
ATTN: GUSTAVO  PRADO              PHONE NO : 858 2021505 
9930 MESA RIM ROAD                SE DECISION MADE: 21-OCT-16
SAN DIEGO CA  92121               510(k) STATEMENT
                                                    

DEVICE: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
M.D.L. S.r.l.                     510(k) NO: K160316(Traditional)
ATTN: Marcello  Dell'Oca          PHONE NO : 39 0342 68213 
Via Tavani 1/a                    SE DECISION MADE: 27-OCT-16
Delebio (So)  IT 23014            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALADDIN HW3.0
VISIA IMAGING S.R.L               510(k) NO: K160327(Traditional)
ATTN: Silvia  Fantechi            PHONE NO : 39 055 9121635 
VIA MARTIRI DELLA LIBERTA 95/E    SE DECISION MADE: 05-OCT-16
San Giovanni Valdarno  IT 52027   510(k) STATEMENT
                                                    

DEVICE: MAGEC® Spinal Bracing and Distraction System
NuVasive Specialized Orthopedics, 510(k) NO: K160352(Traditional)
ATTN: LANCE  JUSTICE              PHONE NO : 949 5446540 
101 ENTERPRISE SUITE 100          SE DECISION MADE: 21-OCT-16
ALISO VIEJO CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPTIMUS CMF SYSTEM
OSTEONIC Co., Ltd.                510(k) NO: K160363(Special)
ATTN: Jisun  Lee                  PHONE NO : 82 2 69028411 
1206ho, 38, Digital-ro 29-gil, GurSE DECISION MADE: 20-OCT-16
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaPACS
NOVARAD CORPORATION               510(k) NO: K160371(Traditional)
ATTN: DOUG  MERRILL               PHONE NO : 801 6421001 
752 EAST 1180 SOUTH #200          SE DECISION MADE: 14-OCT-16
AMERICAN FORK UT  84003           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyto Stethoscope
Tyto Care Ltd.                    510(k) NO: K160401(Traditional)
ATTN: Yoni  Iger                  PHONE NO : 972 54 9599215 
Haomanut 12                       SE DECISION MADE: 19-OCT-16
Netanya  IL 4205445               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
NEURAL ANALYTICS, INC.            510(k) NO: K160442(Traditional)
ATTN: JAY  YONEMOTO               PHONE NO : 310 8191676 
2127 SAWTELLE BLVD                SE DECISION MADE: 21-OCT-16
LOS ANGELES CA  90025             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pleurx Pleural Catheter System
CAREFUSION                        510(k) NO: K160450(Traditional)
ATTN: JOY  GREIDANUS              PHONE NO : 847 3628103 
75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 31-OCT-16
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cutera enlighten III Laser System
Cutera, Inc.                      510(k) NO: K160488(Traditional)
ATTN: Bradley  Renton             PHONE NO : 415 6575568 
3240 Bayshore Blvd.               SE DECISION MADE: 28-OCT-16
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS® Automation Solutions
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K160495(Traditional)
ATTN: Darlene J Phillips          PHONE NO : 585 4534253 
100 Indigo Creek Drive MC00881    SE DECISION MADE: 18-OCT-16
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Link Abutment for CEREC
Osstem Implant Co., Ltd           510(k) NO: K160519(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 28-OCT-16
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
SYSMEX AMERICA, INC.              510(k) NO: K160541(Traditional)
ATTN: Michelle   Parker           PHONE NO : 224 5439639 
577 Aptakisic Road                SE DECISION MADE: 21-OCT-16
Lincolnshire IL  60069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOBLUS™ Ultrasound Diagnostic System
HITACHI MEDICAL CORPORATION       510(k) NO: K160559(Traditional)
ATTN: ANGELA VAN ARSDALE          PHONE NO : 203 2695088 
10 FAIRFIELD BLVD.                SE DECISION MADE: 18-OCT-16
WALLINGFORD CT  06492-7502        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
HARTALEGA SND. BHD.               510(k) NO: K160562(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 60 36277 1733 
C-G-1, JALAN DATARAN SD1 DATARAN SSE DECISION MADE: 13-OCT-16
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
VOLCANO CORPORATION               510(k) NO: K160583(Traditional)
ATTN: BRIAN  PARK                 PHONE NO : 858 7204176 
3721 VALLEY CENTRE DRIVE SUITE 500SE DECISION MADE: 26-OCT-16
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENROUTE 0.014" Guidewire
LAKE REGION MEDICAL               510(k) NO: K160643(Traditional)
ATTN: MICHAEL  DUNNING            PHONE NO : 35 391 385037 
PARKMORE  W BUSINESS PARK         SE DECISION MADE: 18-OCT-16
GALWAY  IE G07001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentiq3D
3D INDUSTRIAL IMAGING CO.,LTD.    510(k) NO: K160666(Traditional)
ATTN: Jin  Sa Kim                 PHONE NO : 82 70 87669192 
413 Institute Of Computer TechnoloSE DECISION MADE: 05-OCT-16
Gwanak-gu  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReNew V Handpiece Laparoscopic Instruments
MICROLINE SURGICAL, INC.          510(k) NO: K160706(Traditional)
ATTN: ANU  GAUR                   PHONE NO : 978 8671726 
50 DUNHAM ROAD, SUITE 1500        SE DECISION MADE: 19-OCT-16
BEVERLY MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LumFix Spinal Fixation Sytem
CG BIO CO., LTD.                  510(k) NO: K160731(Traditional)
ATTN: YUNA  JEONG                 PHONE NO : 82 317 320840 
244, GALMACHI-RO, JUNGWON-GU      SE DECISION MADE: 04-OCT-16
SEONGNAM-SI  KR 13211             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BracePaste Adhesive
American Orthodontics             510(k) NO: K160782(Traditional)
ATTN: Trang  Adams                PHONE NO : 920 4575051 
3524 Washington Avenue            SE DECISION MADE: 14-OCT-16
Sheboygan WI  53081               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rockwell Medical CitraPure Acid Concetrate
ROCKWELL MEDICAL                  510(k) NO: K160847(Traditional)
ATTN: ROBERT  CHIOINI             PHONE NO : 248 9609009 
30142 WIXOM ROAD                  SE DECISION MADE: 20-OCT-16
WIXOM MI  48393                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cryotop Vitrification Kit and Cryotop Thawing Kit
KITAZATO BIOPHARMA CO., LTD.      510(k) NO: K160864(Traditional)
ATTN: FUTOSHI  INOUE              PHONE NO : 81 545 662202 
81 NAKIJIMA                       SE DECISION MADE: 07-OCT-16
FUJI  JP 416-0907                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PaX-i3D Green Premium (Model: PCT-90LH)
VATECH CO., LTD                   510(k) NO: K160882(Traditional)
ATTN: Daniel   Kim                PHONE NO : 82 313 799492 
13, SAMSUNG 1-RO 2-GIL            SE DECISION MADE: 28-OCT-16
HWASEONG-SI  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL D-Dimer HS
INSTRUMENTATION LABORATORY CO.    510(k) NO: K160885(Special)
ATTN: CAROL  MARBLE               PHONE NO : 781 8614467 
180 HARTWELL ROAD                 SE DECISION MADE: 27-OCT-16
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTO Mobility Scooter
Moving Life Ltd                   510(k) NO: K160909(Traditional)
ATTN: Nino A. Ransenberg          PHONE NO : 972 54 5745678 
HaOfe 2                           SE DECISION MADE: 04-OCT-16
Kadima  IL 6092000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilization Tray
STERIS CORPORATION                510(k) NO: K160912(Traditional)
ATTN: ANTHONY  PIOTRKOWSKI        PHONE NO : 440 3927437 
5960 HEISLEY ROAD                 SE DECISION MADE: 07-OCT-16
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gammex Cut-Resistant Glove Liner
ANSELL HEALTHCARE PRODUCTS LLC    510(k) NO: K160974(Traditional)
ATTN: ROBERT  MAHLER              PHONE NO : 732 3455400 
111 WOOD AVENUE SOUTH SUITE 210   SE DECISION MADE: 28-OCT-16
ISELIN NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantera Pro
BIOTRONIK, INC                    510(k) NO: K160985(Traditional)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024  JEAN ROAD                   SE DECISION MADE: 07-OCT-16
LAKE OSWEGO OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HPM-6000
BTL INDUSTRIES, INC.              510(k) NO: K160992(Traditional)
ATTN: JAN  ZARSKY                 PHONE NO : 866 2851656 
47 LORING DRIVE                   SE DECISION MADE: 21-OCT-16
FRAMINGHAM MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HICP200 Patient/Monitor Interconnect Cable
InnerSpace Neuro Solutions, Inc.  510(k) NO: K161010(Traditional)
ATTN: Gary G. Frugard             PHONE NO : 877 4862473 108
1622 Edinger Ave Suite C          SE DECISION MADE: 20-OCT-16
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Clamp ISP System
Zavation, LLC                     510(k) NO: K161016(Traditional)
ATTN: James M Philips             PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 19-OCT-16
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PK Morcellator
GYRUS ACMI, INC.                  510(k) NO: K161038(Traditional)
ATTN: GRAHAM A.L. BAILLIE         PHONE NO : 508 8042738 
136 TURNPIKE RD                   SE DECISION MADE: 07-OCT-16
SOUTHBOROUGH MA  02649            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
Kuraray Noritake Dental, Inc.     510(k) NO: K161042(Traditional)
ATTN: Michio  Takigawa            PHONE NO : 81 3 67011706 
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 25-OCT-16
Chiyoda ku  JP 100-0004           510(k) STATEMENT
                                                    

DEVICE: ACTABOND Topical Skin Adhesive
BERGEN MEDICAL PRODUCTS, INC.     510(k) NO: K161050(Traditional)
ATTN: Tom    Stephens             PHONE NO : 855 8553682 703
16 WING DRIVE                     SE DECISION MADE: 04-OCT-16
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Surgitools Pty Ltd.               510(k) NO: K161065(Traditional)
ATTN: Jai  Singh                  PHONE NO : 61 08 93093222 
231 Timberlane Dr.                SE DECISION MADE: 27-OCT-16
Woodvale  AU 6026                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic HD Hip System
Total Joint Othopedics, Inc.      510(k) NO: K161073(Traditional)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 19-OCT-16
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Epidural Catheter Kit
TELEFLEX MEDICAL, INC.            510(k) NO: K161075(Traditional)
ATTN: ANGELA  BOUSE               PHONE NO : 919 4334904 
3015 CARRINGTON MILL BLVD         SE DECISION MADE: 04-OCT-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSR'obot MRI-US Fusion
BIOBOT SURGICAL PTE LTD           510(k) NO: K161109(Traditional)
ATTN: Lai Chee LIEW               PHONE NO : 65 635 11868 
2 WOODLANDS SPECTRUM 1,  #03-10, WSE DECISION MADE: 06-OCT-16
Singapore  SG 738068              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPetra Suction-Evacuation Sheath
WELL LEAD MEDICAL CO., LTD.       510(k) NO: K161110(Traditional)
ATTN: Han  Guang  Yuan            PHONE NO : 86 20 84758878 
C-4#Jinhu Industrial Estate, HualoSE DECISION MADE: 12-OCT-16
Guangzhou  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navien Intracranial Support Catheter
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K161152(Traditional)
ATTN: Ingrid   Takeuchi           PHONE NO : 949 2979774 
9775 TOLEDO WAY                   SE DECISION MADE: 12-OCT-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNSitu Total Hip System
Theken Companies, LLC             510(k) NO: K161184(Traditional)
ATTN: Dale  Davison               PHONE NO : 330 7337600 
1800 Triplett Blvd.               SE DECISION MADE: 14-OCT-16
Akron OH  44306                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PLEX Elite 9000 SS-OCT
CARL ZEISS MEDITEC, INC.          510(k) NO: K161194(Traditional)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 5605139 
5160 HACIENDA DRIVE               SE DECISION MADE: 26-OCT-16
DUBLIN CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: e-fix E35/E36
Alber GmbH                        510(k) NO: K161241(Traditional)
ATTN: MICHAEL  VENT               PHONE NO : 49 7432 20060 
Vor dem Weissen Stein 21          SE DECISION MADE: 05-OCT-16
Albstadt  DE 72461                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
MEDICO ELECTRODES INTERNATIONAL LT510(k) NO: K161282(Traditional)
ATTN: AMIT   SETH                 PHONE NO : 91 120 3042984 
PLOT 142A/AA, 12, 27, 28 & 29, NOISE DECISION MADE: 30-OCT-16
NOIDA  IN 201305                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniBox +
PULMONE ADVANCED MEDICAL DEVICES, 510(k) NO: K161295(Traditional)
ATTN: Avi   Lazar                 PHONE NO : 972 77 5100938 
14 HACHAROSHET ST                 SE DECISION MADE: 21-OCT-16
Ra’ananna  IL 4365707             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pour Acrylic
Dentsply Sirona                   510(k) NO: K161330(Traditional)
ATTN: Helen  Lewis                PHONE NO : 717 4871332 
221 West Philadelphia Street SuiteSE DECISION MADE: 06-OCT-16
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NanoBone SBX Putty
ARTOSS GMBH                       510(k) NO: K161351(Traditional)
ATTN: Walter  Gerike              PHONE NO : 49 381 54345701 
FRIEDRICH-BARNEWITZ-STR. 3        SE DECISION MADE: 26-OCT-16
ROSTOCK  DE 18119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HawkOne Directional Atherectomy System
Medtronic Vascular, Inc.          510(k) NO: K161361(Traditional)
ATTN: Rupali  Gupta               PHONE NO : 763 3987000 
(formerly d.b.a ev3 Inc., CovidienSE DECISION MADE: 14-OCT-16
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K161393(Traditional)
ATTN: Rafal  Chudzik              PHONE NO : 480 5256006 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 26-OCT-16
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VT·One, VT·One 60days
CARILEX MEDICAL, INC.             510(k) NO: K161410(Traditional)
ATTN: Henry   Kao                 PHONE NO : 886 3 3287882 
No. 77, Keji 1st Rd., Guishan DistSE DECISION MADE: 13-OCT-16
Taoyuan City  TW 333              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
WRP ASIA PACIFIC SDN. BHD.        510(k) NO: K161422(Traditional)
ATTN: SARALA DEVI JAYARAMAN       PHONE NO : 6 03 87061486 
LOT 1, JALAN 3, KAW PERUSAHAAN BANSE DECISION MADE: 20-OCT-16
 SEPANG   MY 43900                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoSpan Compression Staple Impant w/instruments
IN2BONESUSA, LLC                  510(k) NO: K161426(Traditional)
ATTN: JOE  CLIFT                  PHONE NO : 901 2607931 
6060 POPLAR AVE, SUITE 380        SE DECISION MADE: 24-OCT-16
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroSet XT
ORTHOVITA, INC.                   510(k) NO: K161447(Traditional)
ATTN: TINA  MORNAK                PHONE NO : 610 6401775 
45 GREAT VALLEY PARKWAY           SE DECISION MADE: 06-OCT-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Footmotion Plating System
NEWCLIP TECHNICS                  510(k) NO: K161448(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 228 213712 
PA de la Lande Saint Martin-45 rueSE DECISION MADE: 31-OCT-16
HAUTE-GOULAINE  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HammerTech Fixation System
Fusion Orthopedics, LLC           510(k) NO: K161449(Traditional)
ATTN: Adam  Cundiff               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 11-OCT-16
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Indiba USA Inc.                   510(k) NO: K161458(Traditional)
ATTN: Carles  Janer               PHONE NO : 650 8139700 
1717 Embarcadero Road             SE DECISION MADE: 03-OCT-16
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Syringe Dual Pack for Solaris Injectors
Coeur, Inc.                       510(k) NO: K161471(Traditional)
ATTN: Priscilla  Clinner          PHONE NO : 615 5477923 
100 Physicians Way                SE DECISION MADE: 06-OCT-16
Lebanon TN  37090                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
MEDLINE, INDUSTRIES, INC.         510(k) NO: K161473(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
ONE MEDLINE PLACE                 SE DECISION MADE: 19-OCT-16
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2 Dermal Cooling System
R2 Dermatology                    510(k) NO: K161480(Traditional)
ATTN: Kristine  Tatsutani         PHONE NO : 925 3784400 
Bishop Ranch 3 2633 Camino Ramon  SE DECISION MADE: 05-OCT-16
San Ramon CA  94583               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambient HipVac 50 Wand with Integrated Finger Switches
ARTHROCARE CORPORATION            510(k) NO: K161481(Traditional)
ATTN: Ashley  M.  Johnston        PHONE NO : 512 3585762 
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 21-OCT-16
AUSTIN TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unger Quad Injector
STRADIS HEALTHCARE                510(k) NO: K161483(Traditional)
ATTN: Joseph   Trznadel           PHONE NO : 847 5967716 
805 MARATHON PKWY SUITE 100       SE DECISION MADE: 31-OCT-16
LAWRENCEVILLE GA  30046           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turbo-Flo PICC Sets
COOK INCORPORATED                 510(k) NO: K161496(Traditional)
ATTN: Steven   Lawrie             PHONE NO : 812 3353575 104518
750 DANIELS WAY                   SE DECISION MADE: 07-OCT-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implants and Abutments
Ditron Precision Ltd              510(k) NO: K161497(Traditional)
ATTN: Moshe  Orlev                PHONE NO : 972 86 711841 
Haofe 2 St., P.O Box 5010         SE DECISION MADE: 28-OCT-16
Netanya  IL 78150                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEOS Limb Salvage System
Onkos Surgical, Inc.              510(k) NO: K161520(Traditional)
ATTN: Jan  Triani                 PHONE NO : 973 2645400 
77 East Halsey Road               SE DECISION MADE: 28-OCT-16
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTC TENS Device, Model PTS-IV
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K161537(Traditional)
ATTN: WENDY  POON                 PHONE NO : 86 203 8289980 
2ND &3RD FLOOR, BLD.6 DAPIAN INDUSSE DECISION MADE: 13-OCT-16
GUANGZHOU  CN 510665              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Breast Template System
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K161540(Traditional)
ATTN: Peter  J.  Coronado         PHONE NO : 650 6469200 
911 HANSEN WAY                    SE DECISION MADE: 20-OCT-16
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2P SlenGuide
ASHITAKA FACTORY OF TERUMO CORPORA510(k) NO: K161546(Traditional)
ATTN: PHEBE  VARGHESE             PHONE NO : 732 4124166 
150 MAIMAIGI-CHO                  SE DECISION MADE: 14-OCT-16
FUJINOMIYA SHIZUOKA  JP 418-0015  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ NAV1 Electromagnetic Navigation System
KARL STORZ Endoscopy America, Inc.510(k) NO: K161555(Traditional)
ATTN: Leigh  Spotten              PHONE NO : 424 2188738 
2151 E. Grand Ave                 SE DECISION MADE: 21-OCT-16
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter MD300CN310
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K161560(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD, BADACHU HI-TSE DECISION MADE: 05-OCT-16
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
Howmedica Osteonics Corp. aka Stry510(k) NO: K161569(Traditional)
ATTN: Valerie  Giambanco          PHONE NO : 201 8316275 
325 Corporate Drive               SE DECISION MADE: 14-OCT-16
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esophagus Bougie Set
Varian Medical Systems, Inc.      510(k) NO: K161576(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 02-OCT-16
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premier Sealant
PREMIER DENTAL COMPANY PRODUCTS   510(k) NO: K161580(Traditional)
ATTN: VINCENT  D'ALESSANDRO       PHONE NO : 610 2396000 
1710 ROMANO DRIVE                 SE DECISION MADE: 18-OCT-16
PLYMOUTH MEETING PA  19462        510(k) STATEMENT
                                                    

DEVICE: ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
ASAHI INTECC CO.,LTD.             510(k) NO: K161584(Traditional)
ATTN: Yoshihiko   Fukui           PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 06-OCT-16
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSTEM Implant System
OSSTEM IMPLANT CO., LTD.          510(k) NO: K161604(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, BANSONG-RO 513BEON-GIL, HAESE DECISION MADE: 17-OCT-16
Busan  KR 612-070                 510(k) STATEMENT
                                                    

DEVICE: Smart External Drain (SED) System
AQUEDUCT CRITICAL CARE, INC.      510(k) NO: K161605(Traditional)
ATTN: Thomas  Clement             PHONE NO : 425 9851571 
11822 NORTH CREEK PARKWAY NORTH  SSE DECISION MADE: 27-OCT-16
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAVUX™ Cervical Cage
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K161642(Traditional)
ATTN: Margaret  Wong              PHONE NO : 415 9239376 
1331 N. CALIFORNIA BLVD., SUITE 32SE DECISION MADE: 07-OCT-16
WALNUT CREEK CA  94596            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QuantumCam
DDD-DIAGNOSTIC A/S                510(k) NO: K161674(Abbreviated)
ATTN: Niels  Sorensen             PHONE NO : 45 45 768888 
DR. NEERGAARDS VEJ 5E             SE DECISION MADE: 20-OCT-16
HORSHOLM  DK 2970                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q13 SPIROLYSER®
FIM MEDICAL                       510(k) NO: K161676(Traditional)
ATTN: LIZA  PERRAT                PHONE NO : 33 047 2348989 
51 RUE PRIMAT CS 60194            SE DECISION MADE: 20-OCT-16
Villeurbanne Cedex , Rhone  FR 696510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Sterile Healing Solution
Institut Straumann AG             510(k) NO: K161677(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 07-OCT-16
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum LB
Reliance Orthodontic Products Inc.510(k) NO: K161684(Traditional)
ATTN: Paula  Wendland             PHONE NO : 630 7734009 
1540 West Thorndale Ave           SE DECISION MADE: 06-OCT-16
Itasca IL  60143                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-10 Hemoglobin A1c Program
BIO-RAD LABORATORIES, INC.        510(k) NO: K161687(Traditional)
ATTN: JACKIE  BUCKLEY             PHONE NO : 510 7415309 
4000 ALFRED NOBEL DR.             SE DECISION MADE: 14-OCT-16
HERCULES CA  94547                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarent NavWire Sinus Navigation Guidewire
ACCLARENT, INC.                   510(k) NO: K161697(Traditional)
ATTN: ANNA  HWANG                 PHONE NO : 949 7898505 
33 TECHNOLOGY DRIVE               SE DECISION MADE: 24-OCT-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relieva UltirraNav Sinus Balloon Catheter
ACCLARENT, INC.                   510(k) NO: K161698(Traditional)
ATTN: JAMES PATRICK GARVEY        PHONE NO : 949 7898505 
33 TECHNOLOGY DRIVE               SE DECISION MADE: 24-OCT-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO ENT System
BIOSENSE WEBSTER                  510(k) NO: K161701(Traditional)
ATTN: MELISSA C. SCHULTZ          PHONE NO : 909 8398500 
3333 DIAMOND CANYON ROAD          SE DECISION MADE: 24-OCT-16
DIAMOND BAR CA  91765             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
IMMUNALYSIS CORPORATION           510(k) NO: K161714(Traditional)
ATTN: JOSEPH  GINETE              PHONE NO : 909 4820840 
829 TOWNE CENTER DRIVE            SE DECISION MADE: 14-OCT-16
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MaxBlend 2, MaxBlend Lite
Maxtec, LLC                       510(k) NO: K161718(Traditional)
ATTN: Bruce  Brierley             PHONE NO : 385 5498070 
2305 South 1070 West              SE DECISION MADE: 27-OCT-16
Salt Lake City UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Clamp
STANDARD BARIATRICS               510(k) NO: K161720(Traditional)
ATTN: Alison  Sathe               PHONE NO : 513 3047971 
4362 GLENDALE MILFORD RD.         SE DECISION MADE: 24-OCT-16
CINCINNATI OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
MEDELA, INC                       510(k) NO: K161725(Traditional)
ATTN: ROBERT  SOKOLOWSKI          PHONE NO : 815 5782220 
1101 CORPORATE DRIVE              SE DECISION MADE: 28-OCT-16
MCHENRY IL  60050                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eyenez Ophthalmic Camera
EYENEZ LLC                        510(k) NO: K161727(Traditional)
ATTN: DR.  KISLINGER              PHONE NO : 626 3350535 
2619 E.COLORADO BLVD              SE DECISION MADE: 04-OCT-16
PASADENA CA  91107                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapsoCam Plus (SV-3) Capsule Endoscope System
CapsoVision, Inc                  510(k) NO: K161773(Traditional)
ATTN: Azimun  Jamal               PHONE NO : 408 6241488 
18805 Cox Ave., Suite 250         SE DECISION MADE: 21-OCT-16
Saratoga CA  95070                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLumen II Thrombectomy System
Walk Vascular, LLC                510(k) NO: K161786(Traditional)
ATTN: David  Look                 PHONE NO : 949 7529642 
17171 Daimler Street              SE DECISION MADE: 18-OCT-16
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Tubing, Avance Y-Connector, Avance ViewPad
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K161797(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 19-OCT-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Genesee BioMedical, Inc.          510(k) NO: K161815(Traditional)
ATTN: Woodrow G. Mathison         PHONE NO : 303 7773000 
700 W. Mississippi Ave Unit D-5   SE DECISION MADE: 12-OCT-16
Denver CO  80223-4509             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Torcon NB Advantage Catheters
Cook Incorporated                 510(k) NO: K161822(Special)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 27-OCT-16
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: kneeEOS
ONEFIT Medical                    510(k) NO: K161828(Traditional)
ATTN: Julien  Simon               PHONE NO : 33 381 252427 
18 Rue Alain Savary               SE DECISION MADE: 03-OCT-16
Besancon  FR 25000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer M/L Taper Hip Prosthesis
ZIMMER, INC.                      510(k) NO: K161830(Special)
ATTN: RHONDA  MYER                PHONE NO : 574 3719659 
P.O. BOX 708                      SE DECISION MADE: 26-OCT-16
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Overwatch Spine System
Amendia, Inc.                     510(k) NO: K161842(Traditional)
ATTN: Bruce  Hooper               PHONE NO : 877 7553329 
1755 West Oak Parkway             SE DECISION MADE: 13-OCT-16
Marietta GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Arm Bluetooth Blood Pressure Monitor
TRULY INSTRUMENT LIMITED          510(k) NO: K161846(Abbreviated)
ATTN: YANG  JIAN-HO               PHONE NO : 86 0660 3380070 
SITE 2, TRULY INDUSTRY AREA       SE DECISION MADE: 24-OCT-16
SHANWEI  CN 516600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glass Ionomer Cement (Luting)
SHANDONG HUGE DENTAL MATERIAL CORP510(k) NO: K161851(Traditional)
ATTN: STEVEN  SONG                PHONE NO : 086 633 2277285 
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 31-OCT-16
Rizhao City  CN 276800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
THE BINDING SITE GROUP LTD        510(k) NO: K161854(Traditional)
ATTN: ANDREA  THOMAS              PHONE NO : 44 012 14569500 
8 CALTHORPE ROAD                  SE DECISION MADE: 04-OCT-16
EDGBASTON  GB B15 1QT             510(k) STATEMENT
                                                    

DEVICE: PreXion3D Excelsior
PreXion Corporation               510(k) NO: K161881(Traditional)
ATTN: Shumpeita  Torii            PHONE NO : 81 3 52977551 
Funai Tokyo Technology Center BuilSE DECISION MADE: 03-OCT-16
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K161882(Traditional)
ATTN: RESHAM  RAMSAY              PHONE NO : 609 9365529 
311 ENTERPRISE DRIVE              SE DECISION MADE: 14-OCT-16
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Cellfina System
ULTHERA, INC.                     510(k) NO: K161885(Traditional)
ATTN: SUZON  LOMMEL               PHONE NO : 480 6454979 
1840 S Stapley Drive, Suite 200   SE DECISION MADE: 05-OCT-16
Mesa AZ  85204                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K161886(Special)
ATTN: ADA  ZHANG                  PHONE NO : 086 760 85166358 
ZONE B, No.105, DONGLI ROAD, TORCHSE DECISION MADE: 14-OCT-16
ZHONGSHAN  CN 528437              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neuromonitoring Kit
SI-BONE, INC.                     510(k) NO: K161893(Traditional)
ATTN: ROXANNE  DUBOIS             PHONE NO : 408 2070700 2236
3055 OLIN AVE, SUITE 2200         SE DECISION MADE: 18-OCT-16
SAN JOSE CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K161897(Traditional)
ATTN: MARGARET  MARSH             PHONE NO : 210 2556481 
6203 FARINON DRIVE                SE DECISION MADE: 04-OCT-16
SAN ANTONIO TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
ASAHI INTECC CO., LTD.            510(k) NO: K161912(Special)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 52 7681211 
1703 Wakita-cho, Moriyama-ku      SE DECISION MADE: 14-OCT-16
Nagoya  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Laser Therapy Machine
Beijing ADSS Development Co., Ltd 510(k) NO: K161925(Traditional)
ATTN: Gao  Yurong                 PHONE NO : 86 10 83625120 
F6, Xiandao Bldg., Jinyuan Rd. 36 SE DECISION MADE: 05-OCT-16
Beijing  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Toricolors (hioxifilcon D) Soft Contact Lenses
POLYDEV LTD.                      510(k) NO: K161931(Traditional)
ATTN: JOHN  MULVIHILL             PHONE NO : 353 87 6873128 
TINURE RD                         SE DECISION MADE: 12-OCT-16
COLLON  IE                        510(k) STATEMENT
                                                    

DEVICE: CuattroDR
Cuattro, LLC                      510(k) NO: K161937(Traditional)
ATTN: Matthew  Taylor             PHONE NO : 970 752247 
3760 Rocky Mountain Avenue        SE DECISION MADE: 06-OCT-16
Loveland CO  80538                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulsaderm Acne Device
NUTRA LUXE MD, LLC                510(k) NO: K161941(Traditional)
ATTN: GLORIA  AVENDANO            PHONE NO : 239 2087549 
12801 COMMONWEALTH DR. UNIT 2-6   SE DECISION MADE: 19-OCT-16
FORT MYERS FL  33913              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: bk2300
BK MEDICAL APS                    510(k) NO: K161960(Traditional)
ATTN: MICHAEL J. DOYLE            PHONE NO : 978 3264410 
MILEPARKEN 34                     SE DECISION MADE: 17-OCT-16
HERLEV  DK 2730                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur HAV IgM Assay
Siemens Healthcare Diagnostics, In510(k) NO: K161964(Traditional)
ATTN: Philip  Liu                 PHONE NO : 914 5242443 
511 Benedict Avenue               SE DECISION MADE: 13-OCT-16
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-scan Brio, S-scan
Esaote S.p.A.                     510(k) NO: K161973(Traditional)
ATTN: Maria  Marzapane            PHONE NO : 011 39 0554229259 
Via Siffredi 58                   SE DECISION MADE: 25-OCT-16
Genova  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ziehm Solo FD
ZIEHM IMAGING GMBH                510(k) NO: K161976(Traditional)
ATTN: RICHARD L. WESTRICH         PHONE NO : 490 911 2172219 
DONAUSTRASSE 31                   SE DECISION MADE: 06-OCT-16
NUREMBERG  DE D-90451             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olive Plus
AMA NETWORK INC                   510(k) NO: K161981(Traditional)
ATTN: YONG BAIK KIMM              PHONE NO : 909 2747700 
3600 WILSHIRE BLVD #1016          SE DECISION MADE: 14-OCT-16
LOS ANGELES CA  90010             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedDream
SOFTNETA UAB                      510(k) NO: K162011(Traditional)
ATTN: LAURA  BARONIENE            PHONE NO : 370 68835432 
K.BARAUSKO STR. 59                SE DECISION MADE: 14-OCT-16
KAUNAS  LT 51423                  510(k) STATEMENT
                                                    

DEVICE: IntelliSpace Portal Platform
PHILIPS MEDICAL SYSTEMS NEDERLANDS510(k) NO: K162025(Third Party - Traditional)
ATTN: Ilana Ben Moshe             PHONE NO : 972 525 233496 
VEENPLUIS 4-6 Room 542A           SE DECISION MADE: 18-OCT-16
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRAcelet Compression Device
MEDTRONIC VASCULAR                510(k) NO: K162027(Traditional)
ATTN: COLLEEN  MULLINS            PHONE NO : 978 7393267 
37A CHERRY HILL DRIVE             SE DECISION MADE: 21-OCT-16
DANVERS MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 16ch T/R Knee Coil
Quality Electrodynamics, LLC      510(k) NO: K162029(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 4842964 
6655 Beta Drive, Suite 100        SE DECISION MADE: 18-OCT-16
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Temporary External Pacemaker 53401
MEDTRONIC, INC.                   510(k) NO: K162054(Traditional)
ATTN: SYED SUMRAN MOHIUDDIN       PHONE NO : 763 5262380 
8200 CORAL SEA STREET NE          SE DECISION MADE: 18-OCT-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ahmed Glaucoma Valve
NEW WORLD MEDICAL, INC.           510(k) NO: K162060(Traditional)
ATTN: SUHAIL  ABDULLAH            PHONE NO : 909 4664304 
10763 EDISON COURT                SE DECISION MADE: 24-OCT-16
RANCHO CUCAMONGA CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Pedicle Screw System
MEDACTA INTERNATIONAL SA          510(k) NO: K162061(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
STRADA REGINA                     SE DECISION MADE: 21-OCT-16
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasound System SONIMAGE HS1
KONICA MINOLTA, INC.              510(k) NO: K162065(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 19-OCT-16
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: chromID MRSA
bioMerieux, Inc.                  510(k) NO: K162076(Traditional)
ATTN: Karen  Russell              PHONE NO : 314 7318639 
595 Anglum Road                   SE DECISION MADE: 25-OCT-16
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Tandem Diabetes Care, Inc.        510(k) NO: K162080(Traditional)
ATTN: Michael  Sarrasin           PHONE NO : 858 3666900 
11045 Roselle Street              SE DECISION MADE: 25-OCT-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIRO-200NX DP
Hamamatsu Photonics K.K.          510(k) NO: K162117(Traditional)
ATTN: Susumu  Suzuki              PHONE NO : 81 53 4310124 
812 Joko-cho, Higashi-ku          SE DECISION MADE: 25-OCT-16
Hamamatsu City  JP 431-3196       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive CoRoent Small Ti-C System
NUVASIVE, INCORPORATED            510(k) NO: K162138(Traditional)
ATTN: MICHELLE  CHEUNG            PHONE NO : 858 9093360 
7475 LUSK BLVD.                   SE DECISION MADE: 26-OCT-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: vRad PACS with Mammography
Virtual Radiologic Corporation    510(k) NO: K162145(Abbreviated)
ATTN: Melinda  Sewell             PHONE NO : 952 5951100 
11995 Singletree Lane, Suite 500  SE DECISION MADE: 25-OCT-16
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreathID Hp Lab System
Exalenz Bioscience Ltd.           510(k) NO: K162150(Traditional)
ATTN: Raffi  Werner               PHONE NO : 972 8 9737521 
4 Ha'Maayan Street                SE DECISION MADE: 31-OCT-16
Modiin  IL 7177872                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EdgeOne CO2 Laser
Jeisys Medical Inc.               510(k) NO: K162169(Traditional)
ATTN: Erica  Seo                  PHONE NO : 1 714 9225276 
307 Daeryung Techno Town 8th 81-11SE DECISION MADE: 27-OCT-16
Seoul Seoul Teugbyeolsi  KR 153-77510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire NC Plus
OrbusNeich Medical, Inc           510(k) NO: K162209(Special)
ATTN: John D. Pazienza            PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 06-OCT-16
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FortiBridge Anterior Cervical Plate System
NANOVIS SPINE LLC                 510(k) NO: K162250(Special)
ATTN: MATTHEW  HEDRICK            PHONE NO : 877 9076266 
5865 EAST STATE RD. 14            SE DECISION MADE: 26-OCT-16
COLUMBIA CITY IN  46725           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K162256(Traditional)
ATTN: CHRIS  WEABER               PHONE NO : 801 4866070 
1567 E. STRATFORD AVENUE          SE DECISION MADE: 27-OCT-16
SALT LAKE CITY UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare                     510(k) NO: K162269(Special)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Drive, Milwaukee CSE DECISION MADE: 03-OCT-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fluent inflation device
VASCULAR SOLUTIONS, INC.          510(k) NO: K162272(Special)
ATTN: BEKA  VITE                  PHONE NO : 763 6575732 
6464 SYCAMORE COURT NORTH         SE DECISION MADE: 20-OCT-16
MINNEAPOLIS MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solana Strep Complete Assay
Quidel Corporation                510(k) NO: K162274(Traditional)
ATTN: Ronald H Lollar             PHONE NO : 740 5893373 
2005 East State Street, Suite 100 SE DECISION MADE: 25-OCT-16
Athens OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeraQuest Herpes Type 1 Specific IgG
QUEST INTERNATIONAL, INC          510(k) NO: K162276(Traditional)
ATTN: DAVID J. KIEFER             PHONE NO : 305 5926991 
8127 NW 29TH STREET               SE DECISION MADE: 01-OCT-16
MIAMI FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyLabSix CrystaLine
ESAOTE S.P.A.                     510(k) NO: K162290(Traditional)
ATTN: MASSIMO  POLIGNANO          PHONE NO : 39 010 65471 
VIA A. SIFFREDI 58                SE DECISION MADE: 14-OCT-16
GENOVA  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
ST. SHINE OPTICAL CO., LTD.       510(k) NO: K162317(Traditional)
ATTN: ELLA  LEE                   PHONE NO : 886 2 26479356 
4,5F NO. 276-2, SEC. 1, TA TUNG RDSE DECISION MADE: 21-OCT-16
NEW TAIPEI CITY  TW 22146         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
Avinger, Inc                      510(k) NO: K162326(Traditional)
ATTN: Patty  Hevey                PHONE NO : 650 2417004 
400 Chesapeake Drive              SE DECISION MADE: 18-OCT-16
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker OrthoMap Precision Knee system
Stryker Leibinger GmbH & Co. KG   510(k) NO: K162341(Traditional)
ATTN: N/A  N/A                    PHONE NO : 
Boetzinger Strasse 41             SE DECISION MADE: 12-OCT-16
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erisma® LP MIS
CLARIANCE SAS                     510(k) NO: K162367(Traditional)
ATTN: Pascal  ROKEGEM             PHONE NO : 33 3 21161215 
18, rue Robespierre               SE DECISION MADE: 27-OCT-16
BEAURAINS  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc510(k) NO: K162370(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd., Mail Code 65-1A SE DECISION MADE: 25-OCT-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATOR Suture Anchor
KATOR LLC                         510(k) NO: K162386(Special)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West Suite 100      SE DECISION MADE: 25-OCT-16
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Express SD Biliary Monorail Premounted Stent System
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K162404(Traditional)
ATTN: Ka Zoua Xiong               PHONE NO : 763 4942970 
ONE SCIMED PLACE                  SE DECISION MADE: 12-OCT-16
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIREFLY® Pedicle Screw Navigation Guide
MIGHTY OAK MEDICAL INC.           510(k) NO: K162419(Traditional)
ATTN: Mark A. Wylie               PHONE NO : 720 3989703 
750 W. HAMPDEN AVENUE SUITE 120   SE DECISION MADE: 28-OCT-16
Englewood CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Knee System
Total Joint Orthopedics, Inc.     510(k) NO: K162422(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 28-OCT-16
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ulna Plating System
BIOMET INC                        510(k) NO: K162424(Traditional)
ATTN: Julie  Largent              PHONE NO : 305 2696391 
56 E BELL DR                      SE DECISION MADE: 12-OCT-16
WARSAW IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Codman EDS3 CSF External Drainage System
Codman & Shurtleff, Inc.          510(k) NO: K162437(Traditional)
ATTN: Christopher  Garete         PHONE NO : 508 9773869 
325 PARAMOUNT DR.                 SE DECISION MADE: 28-OCT-16
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerPICC Provena Catheters
C.R. BARD, INC.                   510(k) NO: K162443(Special)
ATTN: BRYAN  STONE                PHONE NO : 801 5225876 
605 NORTH 5600 WEST               SE DECISION MADE: 25-OCT-16
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiVac Retractor System
Livac Pty Ltd                     510(k) NO: K162445(Traditional)
ATTN: Anabela  Correia            PHONE NO : 61 41 2003606 
8 Melaleuca Court                 SE DECISION MADE: 20-OCT-16
Warrnambool  AU 3280              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps
Medos International SARL          510(k) NO: K162469(Traditional)
ATTN: Jennifer  Siu               PHONE NO : 508 8283288 
Chemin-Blanc 38                   SE DECISION MADE: 26-OCT-16
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artemis
EIGEN                             510(k) NO: K162474(Traditional)
ATTN: William  Mandel             PHONE NO : 530 2741240 
13366 GRASS VALLEY AVE            SE DECISION MADE: 21-OCT-16
GRASS VALLEY CA  95945            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BSD3543 Digital Flat Panel X-ray Detector
BONTECH INC.                      510(k) NO: K162487(Special)
ATTN: KWANG S. CHOI               PHONE NO : 82 31 3035254 
YOUNGTONG-GU YOUNGTONG-DONG 980-3,SE DECISION MADE: 14-OCT-16
SUWON-SI  KR 443-702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON® Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K162494(Special)
ATTN: Justin  O'Connor            PHONE NO : 901 3463133 
1800 PYRAMID PLACE                SE DECISION MADE: 04-OCT-16
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKR 3000
KONICA MINOLTA, INC               510(k) NO: K162504(Traditional)
ATTN: TSUTOMU  FUKUO              PHONE NO : 81 42 5898429 
1 SAKURA-MACHI                    SE DECISION MADE: 03-OCT-16
HINO-SHI  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys Software v2.0
ARTERYS INC.                      510(k) NO: K162513(Third Party - Traditional)
ATTN: GOLNAZ  MOEINI              PHONE NO : 408 5043187 
51 FEDERAL ST. SUITE 305          SE DECISION MADE: 28-OCT-16
SAN FRANCISCO CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Multichem A1c
Technopath Manufacturing          510(k) NO: K162514(Abbreviated)
ATTN: Bernd  Hass                 PHONE NO : 00353 61 525700 
Fort Henry Business Park          SE DECISION MADE: 26-OCT-16
Ballina  IE                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1012WCC, 1012WGC
RAYENCE CO., LTD.                 510(k) NO: K162518(Special)
ATTN: KEVIN  KIM                  PHONE NO : 82 31 80156459 
14, SAMSUNG 1-RO, 1-GIL           SE DECISION MADE: 06-OCT-16
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1717WCC / 1717WGC
RAYENCE CO., LTD                  510(k) NO: K162519(Special)
ATTN: KEVIN  KIM                  PHONE NO : 82 31 80156459 
14, SAMSUNG 1-RO, 1-GIL           SE DECISION MADE: 06-OCT-16
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve System
Viveve Inc.                       510(k) NO: K162547(Special)
ATTN: Jim  Talbot                 PHONE NO : 408 4703206 
150 Commercial Street             SE DECISION MADE: 06-OCT-16
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumify Ultrasound System
Philips Healthcare                510(k) NO: K162549(Third Party - Traditional)
ATTN: Chuck  Morreale             PHONE NO : 425 4877371 
22100 Bothell Everett Highway     SE DECISION MADE: 03-OCT-16
Bothell WA  98021-8411            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc.                   510(k) NO: K162550(Special)
ATTN: Brenna  Loufek              PHONE NO : 763 5262365 
8200 Coral Sea Street NE          SE DECISION MADE: 12-OCT-16
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gentrix Surgical Matrix
Acell, Inc.                       510(k) NO: K162554(Special)
ATTN: Salman  Elmi                PHONE NO : 410 9538500 
6640 Eli Whitney Drive            SE DECISION MADE: 21-OCT-16
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bioflux Software
Biotricity Inc.                   510(k) NO: K162571(Third Party - Traditional)
ATTN: Tom  Elias                  PHONE NO : 416 2144215 
75 International Blvd, Suite 300  SE DECISION MADE: 13-OCT-16
Toronto  CA M9W 6L9               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VascuCel
Admedus Regen Pty Ltd             510(k) NO: K162579(Special)
ATTN: Mary E. Donlin              PHONE NO : 610 8 92660100 
26 Harris Road                    SE DECISION MADE: 14-OCT-16
Malaga  AU 6090                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaOne Bladeless Trocar
COVIDIEN                          510(k) NO: K162584(Special)
ATTN: TRANG  HUYNH                PHONE NO : 203 4927473 
60 MIDDLETOWN AVE                 SE DECISION MADE: 18-OCT-16
NORTH HAVEN CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HDL-Cholesterol Gen.4
Roche Diagnostics Operations (RDO)510(k) NO: K162593(Traditional)
ATTN: Barbara  McWhorter          PHONE NO : 317 5212336 
9115 Hague Road                   SE DECISION MADE: 19-OCT-16
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIR OPTIX COLORS
Alcon Laboratories, Inc.          510(k) NO: K162596(Special)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 13-OCT-16
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Alcon Laboratories, Inc.          510(k) NO: K162597(Special)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 19-OCT-16
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IcePearl 2.1 CX L, IceForce 2.1 CX L
GALIL MEDICAL LTD.                510(k) NO: K162599(Special)
ATTN: LYNNE  DAVIES               PHONE NO : 621 2875098 
TAVOR 1 BUILDING, INDUSTRIAL PARK,SE DECISION MADE: 11-OCT-16
SHAAR YOKNEAM  IL 2069203         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoPen Echo
Novo Nordisk Inc.                 510(k) NO: K162602(Special)
ATTN: Elizabeth  D'Amato          PHONE NO : 609 9197789 
P.O. Box 846                      SE DECISION MADE: 18-OCT-16
Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinix, INFX-8000V, V6.35
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162614(Special)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 17-OCT-16
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fujifilm Endoscope Models EC-600HL and EC-600LS
FUJIFILM Medical Systems U.S.A., I510(k) NO: K162622(Special)
ATTN: Shraddha  More              PHONE NO : 937 6862627 
10 High Point Drive               SE DECISION MADE: 18-OCT-16
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQM Integral Quality Monitor (also "IQM")
IRT SYSTEMS                       510(k) NO: K162629(Third Party - Traditional)
ATTN: Juergen  Oellig             PHONE NO : 49 261 915450 
SCHLOSSTRASSE 1                   SE DECISION MADE: 20-OCT-16
Koblenz  DE 56068                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Distal Radius Plating System
Miami Device Solutions, LLC       510(k) NO: K162635(Special)
ATTN: Michelle  Montesino         PHONE NO : 786 4221400 
7620 NW 25th Street, Unit 3       SE DECISION MADE: 21-OCT-16
Miami FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Green Smart (Model: PHT-35LHS)
VATECH CO., LTD                   510(k) NO: K162660(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799585 
13, SAMSUNG 1-RO 2-GIL            SE DECISION MADE: 20-OCT-16
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pyrenees Cervical Plate System
K2M, Inc.                         510(k) NO: K162664(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 703 7773155 
600 HOPE PKWY SE                  SE DECISION MADE: 07-OCT-16
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragon 2
MERIDIAN MEDICAL SYSTEMS, LLC     510(k) NO: K162687(Traditional)
ATTN: Larry  Cornell              PHONE NO : 216 5331124 
325 HARRIS DRIVE                  SE DECISION MADE: 21-OCT-16
AURORA OH  442027539              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA MEDICAL, INC.                 510(k) NO: K162695(Special)
ATTN: SHERRIE  COVAL-GOLDSMITH    PHONE NO : 781 5384720 
91 HARTWELL AVENUE                SE DECISION MADE: 25-OCT-16
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
SeaSpine Orthopedics Corporation  510(k) NO: K162715(Special)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 28-OCT-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
Siemens Medical Solutions USA, Inc510(k) NO: K162736(Traditional)
ATTN: ALAINE  MEDIO               PHONE NO : 865 2182703 
810 INNOVATION DRIVE              SE DECISION MADE: 25-OCT-16
KNOXVILLE TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxoGuard Nerve Connector
COOK BIOTECH INCORPORATED         510(k) NO: K162741(Special)
ATTN: PERRY W. GUINN              PHONE NO : 765 4973355 
1425 INNOVATION PLACE             SE DECISION MADE: 31-OCT-16
WEST LAFAYETTE IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Libra Pedicle Screw System
Spinal Balance, Inc.              510(k) NO: K162750(Special)
ATTN: Anand  Agarwal              PHONE NO : 419 5305940 
1510 North Westwood Avenue        SE DECISION MADE: 27-OCT-16
Toledo OH  43606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroBlate System
Monteris Medical, Inc.            510(k) NO: K162762(Special)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North; Suite C  SE DECISION MADE: 26-OCT-16
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Squirt Fluid Delivery System
Merit Medical Systems, Inc.       510(k) NO: K162777(Special)
ATTN: Angela  Brady               PHONE NO : 801 3164818 
1600 W Merit Parkway              SE DECISION MADE: 31-OCT-16
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    


           TOTAL 510(k)s THIS PERIOD   235                                     
           TOTAL WITH SUMMARIES        223                                     
           TOTAL WITH STATEMENTS        12
                                      

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