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  1. 510(k) Clearances

January 2017 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2017


DEVICE: Love Alchemy's Love Lotion
LOVE ALCHEMY LLC                  510(k) NO: K151857(Traditional)
ATTN: Eric  Weiss                 PHONE NO : 
421 KINGSLEY AVE #200             SE DECISION MADE: 09-JAN-17
ORANGE PARK FL  32073             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kolplast Cervical Sample Collection Kit
KOLPLAST CI SA                    510(k) NO: K153128(Traditional)
ATTN: DANIELA  FERACIN            PHONE NO : 55 11 49610972 
ESTRADA MUNICIPAL IVA 136. NO 418.SE DECISION MADE: 13-JAN-17
ITUPEVA- SP   BR 13295-000        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caremed Reusable & Disposable SPO2 Sensors
SHENZHEN CAREMED MEDICAL TECHNOLOG510(k) NO: K153184(Traditional)
ATTN: XINLIN  XIAO                PHONE NO : 86 755 2714369 
ZONE B, 3/F, 11 BUILDING, HEBEI INSE DECISION MADE: 04-JAN-17
SHENZHEN  CN 518021               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Taps for Resorbable Screws
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K153587(Traditional)
ATTN: Susan   Lewandowski         PHONE NO : 610 7195852 
1301 Goshen Parkway               SE DECISION MADE: 18-JAN-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lympha-Flow(LF1200)
DaeSung Maref Co., Ltd            510(k) NO: K160178(Special)
ATTN: Jae-wha  Lee                PHONE NO : 82 31 4597211 
298-24, Gongdan-ro                SE DECISION MADE: 11-JAN-17
Gunpo-si  KR 15809                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AGNES
GOWOONSESANG COSMETICS CO., LTD   510(k) NO: K160469(Traditional)
ATTN: Kyeong Tai Ko               PHONE NO : 82 31 7249009 
(Seohyeon-dong, 4, 5F Cocoplaza), SE DECISION MADE: 05-JAN-17
Seongnam-si  KR 463-824           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Non-Surgical Isolation Gown-
MEDLINE INDUSTRIES, INC.          510(k) NO: K160471(Traditional)
ATTN: PAULINE  MARALIT            PHONE NO : 847 9492283 
ONE MEDLINE PLACE                 SE DECISION MADE: 31-JAN-17
MUNDELEIN IL  60060               510(k) STATEMENT
                                                    

DEVICE: Chaorum Implant System
MEDIMECCA CO., LTD.               510(k) NO: K160536(Traditional)
ATTN: PARK YOUNG WAN              PHONE NO : 82 285 68282 
DAERYUNG TECHNO TOWN 3-CHA 104, 10SE DECISION MADE: 05-JAN-17
SEOUL  KR 153-772                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
CERTA DOSE, INC.                  510(k) NO: K160589(Traditional)
ATTN: SARAH  HANSSEN              PHONE NO : 858 3495906 
573 RACE STREET                   SE DECISION MADE: 19-JAN-17
DEVER CO  80206                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D.O.R.C. Disposable Cryo Probe
DUTCH OPHTHALMIC RESEARCH CENTER I510(k) NO: K160591(Traditional)
ATTN: DANIELLE  SLEEGERS          PHONE NO : 31 181 458080 
SCHEIJDELVEWEG 2                  SE DECISION MADE: 23-JAN-17
ZUIDLAND  NL 3214 VN              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Waste Station
Medline Industries, Inc.          510(k) NO: K160660(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
One Medline Place                 SE DECISION MADE: 19-JAN-17
Mundelein IL  60060               510(k) STATEMENT
                                                    

DEVICE: SuperLine
DENTIUM CO., LTD.                 510(k) NO: K160965(Abbreviated)
ATTN: YOUNJUNG  YUK               PHONE NO : 82 250 18560 
29 TEHERAN-RO, 87-GZL GANGNAM-GU  SE DECISION MADE: 13-JAN-17
SEOUL  KR 446-518                 510(k) STATEMENT
                                                    

DEVICE: Altus Spine Interbody Fusion System
ALTUS PARTNERS, LLC               510(k) NO: K160976(Traditional)
ATTN: Claudia  Hill               PHONE NO : 610 3554156 
5149 WEST CHESTER PIKE            SE DECISION MADE: 25-JAN-17
Newtown Square PA  19073          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neo GBR System 
NEOBIOTECH CO., LTD.              510(k) NO: K160991(Traditional)
ATTN: In Ho  Kim                  PHONE NO : 82 2 5822885 
#312-2,36, Digital-ro 27 gil, GuroSE DECISION MADE: 10-JAN-17
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hospira Extension Set, Hospira Primary Set
HOSPIRA, INC.                     510(k) NO: K161036(Traditional)
ATTN: CHARLES   NEITZEL           PHONE NO : 224 2126087 
375 FIELD DRIVE                   SE DECISION MADE: 06-JAN-17
LAKE FOREST IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cranial PSI
OSSDSIGN AB                       510(k) NO: K161090(Traditional)
ATTN: ULRIK  BIRGERSSON           PHONE NO : 46 0 18553993 
VIRDINGS ALLE 2                   SE DECISION MADE: 19-JAN-17
UPPSALA  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STIMPOD NMS460 Nerve Stimulator
XAVANT TECHNOLOGY (PTY) LTD       510(k) NO: K161091(Traditional)
ATTN: Roche Janse van Rensberg    PHONE NO : 27 0 277435959 
Unit 102 The Tannery Industrial PaSE DECISION MADE: 18-JAN-17
Silverton  ZA 0184                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PANPAC DISPOSABLE VACUUM CURETTES
PANPAC MEDICAL CORPORATION        510(k) NO: K161106(Traditional)
ATTN: YEN-MING  PAN               PHONE NO : 886 2 86472242 
6F-1,2, NO. 202, SEC.3, TA-TONG ROSE DECISION MADE: 13-JAN-17
SHI-CHIH DIST.  TW 22103          510(k) STATEMENT
                                                    

DEVICE: IDS-iSYS Intact PTHN
IMMUNODIAGNOSTIC SYSTEMS LTD      510(k) NO: K161158(Traditional)
ATTN: CHRIS  PRICE                PHONE NO : 44 019 15190660 
10 DIDCOT WAY BOLDON BUSINESS PARKSE DECISION MADE: 31-JAN-17
BOLDON  GB Ne35 9pd               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System
Intuitive Surgical, Inc.          510(k) NO: K161178(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 19-JAN-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 Cryoballoon Ablation System
C2 THERAPEUTICS, INC.             510(k) NO: K161202(Traditional)
ATTN: Theresa   Brandner-Allen    PHONE NO : 650 5215921 
303 CONVENTION WAY, SUITE 1       SE DECISION MADE: 05-JAN-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOCAM Flex HD Camera System 5521
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K161204(Traditional)
ATTN: MIKE  LOITERMAN             PHONE NO : 847 9131113 
353 CORPORATE WOODS PARKWAY       SE DECISION MADE: 11-JAN-17
VERNON HILL IL  60061             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
bioMerieux, Inc.                  510(k) NO: K161217(Traditional)
ATTN: Karen  Russell              PHONE NO : 314 7318639 
595 Anglum Road                   SE DECISION MADE: 12-JAN-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zmaxx T Series
Maxx Digm, Inc.                   510(k) NO: K161219(Traditional)
ATTN: Keith  Jew                  PHONE NO : 408 4629608 
3265 Kifer Road                   SE DECISION MADE: 26-JAN-17
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Facilis™ Spinal System
BAUI BIOTECH CO., LTD.            510(k) NO: K161231(Traditional)
ATTN: BETTY  YEN                  PHONE NO : 886 289 769538 154
6F., NO.8, SEC.1 ZHONGXING RD., WUSE DECISION MADE: 23-JAN-17
NEW TAIPEI CITY  TW 24872         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universa Firm Ureteral Stents and Stent Sets
COOK INCORPORATED                 510(k) NO: K161236(Traditional)
ATTN: JAMIE  RIDNER               PHONE NO : 812 3353575 102834
750 DANIELS WAY                   SE DECISION MADE: 27-JAN-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: meso-relle (AAL34, AAL36, AM30G)
BIOTEKNE SRL                      510(k) NO: K161255(Traditional)
ATTN: Fabio   Tassi               PHONE NO : 39 051 565211 
VIA DELLA BASTIA 9                SE DECISION MADE: 19-JAN-17
CASALECCHIO DI RENO  IT 40033     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CephSimulation 
ANATOMAGE, INC                    510(k) NO: K161270(Traditional)
ATTN: Changxin  Xu                PHONE NO : 408 8851474 108
111N. MARKET ST, #500             SE DECISION MADE: 04-JAN-17
SAN JOSE CA  95113                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
Biomet, Inc.                      510(k) NO: K161273(Traditional)
ATTN: Carmen  Albany              PHONE NO : 574 3713024 
56 East Bell Drive                SE DECISION MADE: 25-JAN-17
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bondiloxs Topical Hemostatic Granules
MEDTRADE PRODUCTS LTD.            510(k) NO: K161274(Traditional)
ATTN: Andrew   Whitton            PHONE NO : 44 1270 503868 
ELECTRA HOUSE CREWE BUSINESS PARK SE DECISION MADE: 18-JAN-17
CREWE  GB CW1 6GL                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
RESEARCH INSTRUMENTS LIMITED      510(k) NO: K161275(Traditional)
ATTN: Wendy  Hassan               PHONE NO : 44 132 6372753 
BICKLAND INDUSTRIAL PARK          SE DECISION MADE: 23-JAN-17
FALMOUTH  GB TR11 4TA             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentalis Bio Solution Implants
DENTALIS BIO SOLUTION IMPLANTS LLC510(k) NO: K161281(Traditional)
ATTN: Osnat  Yanai                PHONE NO : 347 7753350 
2801 FORTUNE CIRCLE E, SUITE B    SE DECISION MADE: 11-JAN-17
Indianapolis IN  46241            510(k) STATEMENT
                                                    

DEVICE: dynaMX™ Compression Plate
MX ORTHOPEDICS, CORP.             510(k) NO: K161303(Traditional)
ATTN: Howard  L. Schrayer         PHONE NO : 617 2078604 
1050 WALTHAM STREET Suite 510     SE DECISION MADE: 26-JAN-17
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cantab Mobile
CAMBRIDGE COGNITION LTD., US AGENT510(k) NO: K161328(Traditional)
ATTN: Nancy  D.  Clementi         PHONE NO : 610 5272600 
TUNBRIDGE COURT, TUNBRIDGE LANE   SE DECISION MADE: 13-JAN-17
Bottisham  GB CB25 9TU            510(k) STATEMENT
                                                    

DEVICE: F&P Brevida™ Nasal Pillows Mask
Fisher & Paykel Healthcare Ltd.   510(k) NO: K161412(Traditional)
ATTN: Amelia  Ortiz               PHONE NO : 64 9 5740100 
15 Maurice Paykel Place, East TamaSE DECISION MADE: 18-JAN-17
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatomic Total Knee System
AMPLITUDE                         510(k) NO: K161414(Traditional)
ATTN: MIREILLE  LEMERY            PHONE NO : 33 475 813495 
11 COURS JACQUES OFFENBACH        SE DECISION MADE: 19-JAN-17
VALENCE  FR 26000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
CARDINAL HEALTH                   510(k) NO: K161418(Traditional)
ATTN: Judith   Harbour            PHONE NO : 847 8872325 
1500 S Waukegan Rd                SE DECISION MADE: 19-JAN-17
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SureClip(TM) Repositionable Hemostasis Clip
Micro-Tech (Nanjing) CO., Ltd.    510(k) NO: K161463(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 06-JAN-17
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
ORTHOFIX SRL                      510(k) NO: K161466(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
VIA DELLE NAZIONI 9               SE DECISION MADE: 24-JAN-17
BUSSOLENGO (VR)  IT 37012         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Juno VPAP ST-A
ResMed Ltd                        510(k) NO: K161492(Traditional)
ATTN: Jean-Nicolas  Boudaud       PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 19-JAN-17
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Turbo-Flo HD Acute Hemodialysis  Catheter Set/Tray
COOK INCORPORATED                 510(k) NO: K161504(Special)
ATTN: Steven  Lawrie              PHONE NO : 812 3353575 104518
750 DANIELS WAY                   SE DECISION MADE: 06-JAN-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceruloplasmin 
BECKMAN COULTER IRELAND INC.      510(k) NO: K161508(Traditional)
ATTN: MARGUERITA  SWEENEY         PHONE NO : 353 65 6831495 
LISMEEHAN O' CALLAGHAN'S, MILLS   SE DECISION MADE: 09-JAN-17
CO. CLARE  IE                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Thin Reciprocating Blade, 0.010in.
STRYKER CORPORATION               510(k) NO: K161514(Traditional)
ATTN: Joanna   McCarthy           PHONE NO : 011 353 21453296 
4100 E. MILHAM AVE                SE DECISION MADE: 17-JAN-17
KALAMAZOO MI  49009               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mortara Surveyor Patient Monitor
MORTARA INSTRUMENT, INC.          510(k) NO: K161517(Traditional)
ATTN: SARAH  WEBER                PHONE NO : 414 3541600 
7865 NORTH 86TH STREET            SE DECISION MADE: 11-JAN-17
MILWAUKEE WI  53224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyOne Air Spirometer
NDD MEDIZINTECHNIK AG             510(k) NO: K161536(Traditional)
ATTN: JERRY  MASIELLO             PHONE NO : 41 44 4452530 
TECHNOPARKSTRASSE 1               SE DECISION MADE: 05-JAN-17
ZURICH  CH 8005                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMI Frontier Dental Implant System
ILERIMPLANT S.L.                  510(k) NO: K161593(Traditional)
ATTN: ANTONIO  COSO               PHONE NO : 34 973 184350 
C/ ENGINYER MIES, 705-B           SE DECISION MADE: 19-JAN-17
LLEIDA  ES 25191                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Poseidon OCT Spinal Fixation System
Medyssey USA, Inc.                510(k) NO: K161637(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 847 4270200 
1550 E. Higgins Road, Suite 123   SE DECISION MADE: 05-JAN-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOSPA IS ACP System
CORENTEC CO., LTD                 510(k) NO: K161641(Traditional)
ATTN: J.S.  DANIEL                PHONE NO : 82 41 5857144 
12, YEONGSANHONG 1-GIL, IPJANG-MYESE DECISION MADE: 05-JAN-17
CHEONAN-SI  KR 31056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polysmith Sleep System, Model NTI7593
Neurotronics, Inc.                510(k) NO: K161650(Traditional)
ATTN: David  Pezet                PHONE NO : 352 3729955 
3600 NW 43rd Street, STE F1       SE DECISION MADE: 19-JAN-17
Gainesville FL  32606             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P InfoSmart
FISHER & PAYKEL HEALTHCARE LTD.   510(k) NO: K161686(Traditional)
ATTN: Jayanti  Karandikar         PHONE NO : 64 095 740100 
15 MAURICE PAYKEL PLACE           SE DECISION MADE: 24-JAN-17
East Tamaki  NZ 2013              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Gynecological Applicator
NUCLETRON BV                      510(k) NO: K161688(Traditional)
ATTN: RUDOLF  VOS                 PHONE NO : 31 318 557133 
WAARDGELDER 1                     SE DECISION MADE: 27-JAN-17
VEENENDAAL  NL 3905 TH            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaMatrix/Dynamatrix Plus
COOK BIOTECH INCORPORATED         510(k) NO: K161762(Special)
ATTN: Perry W. Guinn              PHONE NO : 765 4973355 
1425 INNOVATION PLACE             SE DECISION MADE: 13-JAN-17
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips IntelliVue GuardianSoftware
PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K161767(Traditional)
ATTN: Michael  Asmalsky           PHONE NO : 49 7031 4631277 
HEWLETT-PACKARD STR. 2            SE DECISION MADE: 27-JAN-17
BOEBLINGEN  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
WRP ASIA PACIFIC SDN BHD          510(k) NO: K161823(Traditional)
ATTN: SARALA DEVI JAYARAMAN       PHONE NO : 60 387 061486 
LOT 1, JALAN 3, KAW PERUSAHAAN BANSE DECISION MADE: 23-JAN-17
SEPANG  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D2P
3D SYSTEMS, INC.                  510(k) NO: K161841(Traditional)
ATTN: KIM  TORLUEMKE              PHONE NO : 972 3 9114206 
CORNER OF GOLAN AND HANEGEV STREETSE DECISION MADE: 09-JAN-17
AIRPORT CITY  IL 70151            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meridian M110 Fetal Monitoring System
MINDCHILD MEDICAL                 510(k) NO: K161902(Traditional)
ATTN: JIM  ROBERTSON              PHONE NO : 978 9751160 
1600 OSGOOD STREET #2-17          SE DECISION MADE: 12-JAN-17
NORTH ANDOVER MA  01845           510(k) STATEMENT
                                                    

DEVICE: GEO Bone Screw System
GRAMERCY EXTREMITY ORTHOPEIDICS, L510(k) NO: K161904(Traditional)
ATTN: MICHAEL P. SIMPSON          PHONE NO : 
1239 N. GLENVILLE DR.             SE DECISION MADE: 18-JAN-17
RICHARDSON TX  75081              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoCool V-3 RF Ablation System
Baylis Medical Company Inc.       510(k) NO: K161949(Traditional)
ATTN: Meghal  Khakhar             PHONE NO : 905 6024875 
2645 Matheson Blvd. East          SE DECISION MADE: 31-JAN-17
Mississauga  CA L4W 5S4           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
Callisyn Biomedical, Inc.         510(k) NO: K161967(Traditional)
ATTN: Shallwei  Sun               PHONE NO : 978 6870596 
260 Candlestick Road              SE DECISION MADE: 27-JAN-17
North Andover MA  01845           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bindex BI-2
BONE INDEX FINLAND, LTD.          510(k) NO: K161971(Abbreviated)
ATTN: Janne  Karjalainen          PHONE NO : 358 40 7079892 
MICROKATU 1                       SE DECISION MADE: 09-JAN-17
KUOPIO  FI 70211                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OBS Electrosurgical Generator (Model: OBS-350A)
Baisheng Medical Co.,Ltd.         510(k) NO: K162034(Third Party - Traditional)
ATTN: Peter  Mao                  PHONE NO : 86 750 6628113 809
No.11 Fusheng Road, Xinhui DistricSE DECISION MADE: 30-JAN-17
Jiangmen  CN 529100               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Acclarix LX8 Diagnostic Ultrasound System
EDAN INSTRUMENTS INC              510(k) NO: K162055(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 31-JAN-17
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ConceptoMed Luer-Jack Slip 10ml
ConceptoMed AS                    510(k) NO: K162057(Traditional)
ATTN: Marit  Martinsen            PHONE NO : 47 760 89000 
Hattvikveien 2                    SE DECISION MADE: 11-JAN-17
Ballstad  NO N-8373               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossBay IVF Embryo Transfer Catheter Set
CrossBay Medical Inc.             510(k) NO: K162064(Traditional)
ATTN: Piush  Vidyarthi            PHONE NO : 415 7282847 
13240 Evening Creek Drive, Suite 3SE DECISION MADE: 05-JAN-17
San Diego CA  92128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RII Multi-function Infrared Thermometer, Model TH52Z
Radiant Innovation Inc.           510(k) NO: K162083(Traditional)
ATTN: Monica  Chung               PHONE NO : 886 3 6111666 
1F, No.3 Industrial E. 9th Rd. SciSE DECISION MADE: 09-JAN-17
HsinChu  TW 30075                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOTO Partial Knee System
Medacta International SA          510(k) NO: K162084(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 03-JAN-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiStim ECO
PAJUNK GmbH Medizintechnologie    510(k) NO: K162086(Traditional)
ATTN: Christian  Quass            PHONE NO : 490 7704 9291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 06-JAN-17
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ecomed Disposable Angiographic Syringes
ECOMED SOLUTIONS, LLC             510(k) NO: K162088(Traditional)
ATTN: DAVID  YUREK                PHONE NO : 847 9840106 
214 TERRACE DR                    SE DECISION MADE: 27-JAN-17
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED Phototherapy Device
LI-TEK ELECTRONIC TECHNOLOGY CORPO510(k) NO: K162098(Traditional)
ATTN: Barry  Yuan                 PHONE NO : 86 0769 83117755 
NO.8-13, THE INDUSTRIAL PARK OF JISE DECISION MADE: 30-JAN-17
DONGGUAN  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Siconus SI Joint Fixation System
CAMBER SPINE TECHNOLOGIES         510(k) NO: K162121(Traditional)
ATTN: DAMIAN  HEINZ               PHONE NO : 855 8999869 
418 E. LANCASTER AVE              SE DECISION MADE: 18-JAN-17
WAYNE PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fever Scout™ Continuous Monitoring thermometer
VivaLnk Inc.                      510(k) NO: K162137(Traditional)
ATTN: Cecilia  Xi                 PHONE NO : 408 8682898 
4655 Old Ironsides Dr. #390       SE DECISION MADE: 19-JAN-17
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
BRIGHTWAY HOLDINGS SDN BHD.       510(k) NO: K162146(Traditional)
ATTN: G.  BASKARAN                PHONE NO : 603 33431007 
LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 05-JAN-17
KLANG  MY 42100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
KERR CORPORATION                  510(k) NO: K162164(Traditional)
ATTN: MOHAMMAD SAAD ANSARI        PHONE NO : 909 9625644 
1717 W. COLLINS AVE               SE DECISION MADE: 13-JAN-17
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys CYFRA 21-1 CalCheck 5
Roche Diagnostics                 510(k) NO: K162173(Traditional)
ATTN: Adam  Clark                 PHONE NO : 317 5214371 
9115 Hague Road                   SE DECISION MADE: 12-JAN-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: osteo-WEDGE II ® Open Wedge Bone Locking Plate System
GRAHAM MEDICAL TECHNOLOGIES, L.L.C510(k) NO: K162179(Traditional)
ATTN: Angela  Recchia             PHONE NO : 586 6779600 
16137 LEONE DRIVE                 SE DECISION MADE: 10-JAN-17
Macomb MI  48042                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
CARDIACASSIST INC.                510(k) NO: K162181(Traditional)
ATTN: GREG  JOHNSON               PHONE NO : 412 9637770 266
240 ALPHA DRIVE                   SE DECISION MADE: 06-JAN-17
PITTSBURGH PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoClot
EndoClot Plus Co., Ltd.           510(k) NO: K162197(Traditional)
ATTN: Hendry  Zhang               PHONE NO : 086 512 62605550 
101 Room, B8 Building, 218 Xinghu SE DECISION MADE: 18-JAN-17
SuZhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Desara TV, Desara Blue TV
CALDERA MEDICAL, INC.             510(k) NO: K162201(Traditional)
ATTN: Vicki  Gail                 PHONE NO : 818 4837602 
5171 CLARETON DRIVE               SE DECISION MADE: 11-JAN-17
Agoura Hills CA  91301            510(k) STATEMENT
                                                    

DEVICE: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
BECKMAN COULTER INC.              510(k) NO: K162208(Traditional)
ATTN: Geraldine  Fuentespina      PHONE NO : 714 9613777 
250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 09-JAN-17
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
SUPERVISION OPTIMAX SDN BHD       510(k) NO: K162223(Traditional)
ATTN: YAP PEAK GEEH               PHONE NO : 60 361 452328 
LOT 38, PUTRA INDUSTRIAL PARK, BUKSE DECISION MADE: 04-JAN-17
SUNGAI BULOH  MY 40160            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliant Multistage Dilatation Balloon Catheter
Micro-Tech (Nanjing) CO., Ltd.    510(k) NO: K162226(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 25-JAN-17
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Truscope Ultra Patient Monitor
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K162234(Special)
ATTN: Jing  Liang                 PHONE NO : 86 756 3399967 
INNOVATION FIRST ROAD TECHNOLOGY ISE DECISION MADE: 04-JAN-17
ZHUHAI,  CN 519085                510(k) STATEMENT
                                                    

DEVICE: Comfort Flo Humidification System
TELEFLEX MEDICAL, INC             510(k) NO: K162242(Traditional)
ATTN: BRIAN  GALL                 PHONE NO : 919 2284350 
2917 WECK DRIVE                   SE DECISION MADE: 19-JAN-17
RESEARCH TRIANGLE PARK NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trapper Exchange Device
CREGANNA MEDICAL ASLO BUSINESS AS 510(k) NO: K162253(Traditional)
ATTN: ORLA  HICKEY                PHONE NO : 353 917 83438 
PARKMORE WEST                     SE DECISION MADE: 06-JAN-17
GALWAY  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CERAMAGE UP
SHOFU DENTAL CORPORATION          510(k) NO: K162261(Traditional)
ATTN: MAURO  MALZYNER             PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 11-JAN-17
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    

DEVICE: EBM iDO Viewer 1.2.1
EBM Technologies Incorporated     510(k) NO: K162285(Traditional)
ATTN: John  Su                    PHONE NO : 808 3976809 
5F., No. 516, Sec. 1, Neihu Rd    SE DECISION MADE: 27-JAN-17
Taipei  TW 114                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tooth Shade Resin Material
LIAONING UPCERA CO.,LTD           510(k) NO: K162323(Traditional)
ATTN: Charles  Shen               PHONE NO : 086 24 45565006 
NO.122 XIANGHUAI ROAD, ECONOMIC DESE DECISION MADE: 12-JAN-17
BENXI  CN 117004                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Contour Next EZ Blood Glucose Monitoring System
Ascensia Diabetes Care US Inc.    510(k) NO: K162336(Special)
ATTN: Jennifer L. Gregory         PHONE NO : 574 2563447 
430 South Beiger Street           SE DECISION MADE: 12-JAN-17
Mishawaka IN  46544               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
HEALTHY GLOVE CO., LTD            510(k) NO: K162381(Traditional)
ATTN: Teoh Choh Shee              PHONE NO : 66 74 536815 
119 Kanchanavanich Road, Tambol PaSE DECISION MADE: 31-JAN-17
Hat Yai  TH 90230                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U-IGNITE Bladeless Trocar
TIANJIN UWELL MEDICAL DEVICE MANUF510(k) NO: K162387(Traditional)
ATTN: TAO  FAN                    PHONE NO : 86 22 58775333 
A02, PLANT B, NO. 278, HANGKONG RDSE DECISION MADE: 11-JAN-17
TIANJIN  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ET Hybrid Abutment
HIOSSEN INC.                      510(k) NO: K162390(Traditional)
ATTN: David  Kim                  PHONE NO : 888 6780001 
85 BEN FAIRLESS DR.               SE DECISION MADE: 30-JAN-17
FAIRLESS HILLS PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titan 3 Low Speed Angle Attachments
DENTALEZ, INC                     510(k) NO: K162397(Traditional)
ATTN: Dan  Laskowitz              PHONE NO : 717 2911161 
1816 COLONIAL VILLAGE LANE        SE DECISION MADE: 19-JAN-17
Lancaster PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica CH Magnesium (Mg)
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K162399(Traditional)
ATTN: LAURA J. DUGGAN             PHONE NO : 302 6317654 
500 GBC DRIVE, PO BOX 6101 MS 514 SE DECISION MADE: 19-JAN-17
NEWARK DE  19711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: L300 Go System
BIONESS INC.                      510(k) NO: K162407(Traditional)
ATTN: MERCEDES  BAYANI            PHONE NO : 661 3626690 
25103 RYE CANYON LOOP             SE DECISION MADE: 27-JAN-17
VALENCIA CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
HAEMONETICS CORPORATION           510(k) NO: K162423(Traditional)
ATTN: MARK  ANZALONE              PHONE NO : 781 3569912 
400 WOOD ROAD                     SE DECISION MADE: 03-JAN-17
BRAINTREE MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vado Bi-Directional Steerable Sheath
KALILA MEDICAL, INC.              510(k) NO: K162427(Traditional)
ATTN: CARRIE  NEUBERGER           PHONE NO : 415 6403377 
745 CAMDEN AVE, SUITE A           SE DECISION MADE: 27-JAN-17
CAMPBELL CA  95008-4146           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniStrip1 Generic Blood Glucose Test Strips
OK BIOTECH CO., LTD.              510(k) NO: K162430(Traditional)
ATTN: KE-MIN  JEN                 PHONE NO : 886 351 60258 
NO.91, SEC.2 GONGDAO 5TH ROAD     SE DECISION MADE: 19-JAN-17
HSINCHU CITY  TW 30070            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-Link X2 ECG Cable and Lead Wire System
CAREFUSION 2200 INC.              510(k) NO: K162432(Traditional)
ATTN: ERIKA  FERNANDEZ            PHONE NO : 847 3628097 
75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 18-JAN-17
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NC Gallant PTCA Catheter
MEDINOL LTD.                      510(k) NO: K162434(Traditional)
ATTN: MICHAL  HERSHKOVITZ         PHONE NO : 972 3 7679000 
KIRYAT ATIDIM, BUILDING 8         SE DECISION MADE: 19-JAN-17
TEL AVIV  IL 6158101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Humelock Reversed Shoulder
FX SOLUTIONS                      510(k) NO: K162455(Traditional)
ATTN: Jean-Jacques  Martin        PHONE NO : 33 4 74553555 
1663 RUE DE MAJORNAS              SE DECISION MADE: 17-JAN-17
VIRIAT  FR 01440                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrueBeam-TrueBeam STx-Edge
Varian Medical Systems, Inc.      510(k) NO: K162472(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 19-JAN-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symbia Intevo Bold
SIEMENS MEDICAL SOLUTIONS, USA, IN510(k) NO: K162483(Traditional)
ATTN: Cynthia  Busch              PHONE NO : 847 3047095 
2501 N. BARRINGTON ROAD           SE DECISION MADE: 09-JAN-17
Hoffman Estates IL  60192-2061    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RED Light Device
Zhongshan Bisen Plastic Electronic510(k) NO: K162489(Traditional)
ATTN: FengPing  Li                PHONE NO : 86 760 88297142 
F2,Bldg1,No.8,Dongzhen North Rd,ZhSE DECISION MADE: 13-JAN-17
Zhong Shan  CN 528437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disc-FX System
ELLIQUENCE LLC                    510(k) NO: K162490(Traditional)
ATTN: Paul D. Buhrke IV           PHONE NO : 516 2779010 
2455 Grand Avenue                 SE DECISION MADE: 06-JAN-17
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ostial Sprit Cannulae
SPYDER MEDICAL                    510(k) NO: K162500(Traditional)
ATTN: MICHAEL  WEBB               PHONE NO : 949 5339982 
22521 AVENIDA EMPRESA, SUITE 111  SE DECISION MADE: 12-JAN-17
RANCHO SANTA MARGARITA CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LELO RESPECT HEX Natural Rubber Latex Condom
LELO INC.                         510(k) NO: K162511(Special)
ATTN: PAVLE  SEDIC                PHONE NO : 408 2494000 
4320 STEVENS CREEK BLVD., SUITE 20SE DECISION MADE: 13-JAN-17
SAN JOSE CA  95129                510(k) STATEMENT
                                                    

DEVICE: WellDoc BlueStar, WellDoc BlueStar Rx
WELLDOC, INC                      510(k) NO: K162532(Traditional)
ATTN: DANIELLE  DORFMAN           PHONE NO : 443 6923100 
10221 WINCOPIN CIRCLE SUITE 150   SE DECISION MADE: 12-JAN-17
COLUMBIA MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters
SPECTRANETICS, INC.               510(k) NO: K162561(Traditional)
ATTN: PRISCILA  TAPIA             PHONE NO : 719 4472587 
9965 FEDERAL DRIVE                SE DECISION MADE: 05-JAN-17
COLORADO SPRINGS CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YOGA Microcatheter
CODMAN & SHURTLEFF, INC.          510(k) NO: K162563(Special)
ATTN: YOON HEE BEATTY             PHONE NO : 305 2652919 
325 PARAMOUNT DRIVE               SE DECISION MADE: 05-JAN-17
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROCCIA® ACIF
SILONY MEDICAL GMBH               510(k) NO: K162587(Traditional)
ATTN: Bircan  YILMAZ              PHONE NO : 49 711 78252540 
LEINFELDER STRASSE 60             SE DECISION MADE: 26-JAN-17
Leinfelden-Echterdingen  DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys TSH assay, cobas e 801 Immunoassay analyzer
ROCHE DIAGNOSTICS                 510(k) NO: K162606(Traditional)
ATTN: ANGELO  PEREIRA             PHONE NO : 317 5213544 
9115 HAGUE ROAD                   SE DECISION MADE: 23-JAN-17
INDIANAPOLIS IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONCORD Plus Radiopaque Bone Cement
GLOBUS MEDICAL, INC.              510(k) NO: K162618(Traditional)
ATTN: KELLY J. BAKER              PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 23-JAN-17
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY STEAM Integrating Indicator - Short
STERIS CORPORATION                510(k) NO: K162631(Traditional)
ATTN: TRICIA  CREGGER             PHONE NO : 440 3927189 
5960 HEISLEY ROAD                 SE DECISION MADE: 27-JAN-17
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Breast BI 7 MR Coil Mammavention 3T
MORAS MRI products GmbH           510(k) NO: K162651(Traditional)
ATTN: Zahed  Sedighiani           PHONE NO : 49 931 2992717 
Leibnizstr. 4                     SE DECISION MADE: 18-JAN-17
Hoechberg  DE 97204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
WELL-LIFE HEALTHCARE LIMITED      510(k) NO: K162663(Traditional)
ATTN: CHIN-CHIH  HSIEH            PHONE NO : 886 2 29282112 
1F, NO. 16, LANE 454, JUNGJENG ROASE DECISION MADE: 17-JAN-17
YUNGHE DISTRICT, NEW TAIPEI CITY  510(k) STATEMENT
                                                    

DEVICE: Ayers Rock Cervical interbody fusion system
Spineway                          510(k) NO: K162694(Traditional)
ATTN: Nicolas  Roth               PHONE NO : 330 4 72770152 
7 Allee Moulin Berger Ecully FrancSE DECISION MADE: 12-JAN-17
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axium Prime Detachable Coil System
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K162704(Traditional)
ATTN: Joyce  Zhong                PHONE NO : 949 6801307 
9775 Toledo Way                   SE DECISION MADE: 03-JAN-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
MAINE STANDARDS COMPANY LLC       510(k) NO: K162705(Traditional)
ATTN: JAMES  CHAMPLIN             PHONE NO : 207 8921300 
221 US ROUTE 1                    SE DECISION MADE: 05-JAN-17
CUMBERLAND FORESIDE ME  04110     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FREND Vitamin D Test System
NanoEnTek USA, Inc.               510(k) NO: K162754(Traditional)
ATTN: Jimmy  Chen                 PHONE NO : 925 2250108 
5627 Stoneridge Drive Suite 304   SE DECISION MADE: 12-JAN-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vevazz LED Heat Lamp
Vevazz, LLC                       510(k) NO: K162763(Traditional)
ATTN: Jamie  Fettig               PHONE NO : 773 6654005 
30520 Rancho California Rd, Suite SE DECISION MADE: 05-JAN-17
Temecula CA  92591                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ FRAME SYSTEM
IMPLANET S.A.                     510(k) NO: K162764(Traditional)
ATTN: REGIS  LE COUEDIC           PHONE NO : 33 557 9955555 
TECHNOPOLE BORDEAUX MONTESQUIEU ALSE DECISION MADE: 19-JAN-17
MARTILLAC  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Velocity Diode Laser System
Venus Concept Ltd.                510(k) NO: K162765(Traditional)
ATTN: Tal  Bresler-Stramer        PHONE NO : 416 9070115 
4556 N. Hiatus Road               SE DECISION MADE: 11-JAN-17
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentinel BreastScan II System
First Sense Medical, LLC          510(k) NO: K162767(Special)
ATTN: Alan  Alan Klevens          PHONE NO : 248 3923006 
2001 Centerpoint Parkways, Suite 1SE DECISION MADE: 09-JAN-17
Pontiac MI  48341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relign System
Relign Corporation                510(k) NO: K162770(Traditional)
ATTN: Nathan  Nguyen              PHONE NO : 408 9962517 320
1601 South De Anza Boulevard, SuitSE DECISION MADE: 04-JAN-17
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Legion Cone System
Smith & Nephew, Inc.              510(k) NO: K162775(Traditional)
ATTN: Natalie  Williams           PHONE NO : 901 3995161 
7135 Goodlett Farms Parkway       SE DECISION MADE: 13-JAN-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASS LP Spinal System
MEDICREA INTERNATIONAL S.A        510(k) NO: K162786(Traditional)
ATTN: DAVID  RYAN                 PHONE NO : 33 472 018788 
14 Z.A PORTE DU GRAND LYON        SE DECISION MADE: 25-JAN-17
NEYRON  FR 01700                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V.A.C.ULTA Negative Pressure Wound Therapy System
KCI USA, Inc. (Kinetic Concepts, I510(k) NO: K162790(Traditional)
ATTN: Margaret  Marsh             PHONE NO : 210 2556481 
6203 Farinon Drive                SE DECISION MADE: 26-JAN-17
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barrx Anorectal RFA Wand
COVIDIEN LLC                      510(k) NO: K162802(Traditional)
ATTN: RACHEL  SILVA               PHONE NO : 408 3287359 
15 HAMPSHIRE STREET               SE DECISION MADE: 24-JAN-17
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Akros Fibulink Syndesmosis Repair Kit
Akros Medical                     510(k) NO: K162805(Traditional)
ATTN: Charles  Horrell            PHONE NO : 248 2595535 
3503 Pleasant Green Rd            SE DECISION MADE: 10-JAN-17
Durham NC  27705                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InSeca ARC Stylus, Aerin Console
Aerin Medical, Inc.               510(k) NO: K162810(Traditional)
ATTN: Scott  Wolf                 PHONE NO : 650 4343247 
690 W. Fremont Avenue, Unit 3     SE DECISION MADE: 11-JAN-17
Sunnyvale CA  94087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noddle(TM)
IOWA ADAPTIVE TECHNOLOGIES, INC. D510(k) NO: K162817(Traditional)
ATTN: R.  RIVES BIRD              PHONE NO : 319 3825459 
2500 CROSSPARK ROAD STE W150      SE DECISION MADE: 18-JAN-17
CORALVILLE IA  52241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
HARTALEGA SDN. BHD.               510(k) NO: K162818(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 62771733 
DATARAN SD PJU 9                  SE DECISION MADE: 09-JAN-17
BANDAR SERI DAMANSARA  MY 52200   510(k) STATEMENT
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
HARTALEGA SDN. BHD.               510(k) NO: K162819(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 62771733 
DATARAN SD PJU 9                  SE DECISION MADE: 09-JAN-17
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: ASAHI PTCA Guide Wire ASAHI SUOH 03
ASAHI INTECC CO., LTD.            510(k) NO: K162842(Traditional)
ATTN: YASUYUKI  KAWAHARA          PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 27-JAN-17
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eLyx-PRO
Intelligent Sensory Concept SA    510(k) NO: K162851(Traditional)
ATTN: Joel  Chanteraud            PHONE NO : 41 786 514945 
Rue du Tasson 3                   SE DECISION MADE: 24-JAN-17
SENARCLENS  CH 1304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoVation Impact
Skeletal Kinetics, LLC.           510(k) NO: K162864(Traditional)
ATTN: Alicia  Hemphill            PHONE NO : 972 6774783 
10201 Bubb Road                   SE DECISION MADE: 13-JAN-17
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elite Expandable Interbody Fusion Device
Spineology Inc.                   510(k) NO: K162879(Traditional)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 30-JAN-17
St. Paul MN  55127                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ ICG Imaging System
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K162882(Traditional)
ATTN: SUSIE S. CHEN               PHONE NO : 424 2188201 
2151 E. GRAND AVENUE              SE DECISION MADE: 26-JAN-17
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpineGuard DSG Zavation Screw System
SPINEGUARD,S.A.                   510(k) NO: K162884(Traditional)
ATTN: Stephane  Bette             PHONE NO : 33 1 45184519 
10 cours Louis Lumiere            SE DECISION MADE: 12-JAN-17
Vincennes  FR 94300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPY Phi Open Field Handheld Fluorescence Imaging System
NOVADAQ TECHNOLOGIES INC.         510(k) NO: K162885(Traditional)
ATTN: JEN  PENDLEBURY             PHONE NO : 905 6293822 205
8329 EASTLAKE DRIVE UNIT 101      SE DECISION MADE: 11-JAN-17
Burnaby  CA V5A 4W2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PrismaSATE
Baxter Healthcare Corporation     510(k) NO: K162887(Special)
ATTN: Kristen  Bozzelli           PHONE NO : 224 2703075 
32650 North Wilson Road           SE DECISION MADE: 06-JAN-17
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
Roche Diagnostics                 510(k) NO: K162895(Traditional)
ATTN: Jane  Phillips              PHONE NO : 317 521 3338
9115 Hague Road                   SE DECISION MADE: 18-JAN-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CSX-30 Flat Panel Detector
Canon, Inc. – Medical Equipment Gr510(k) NO: K162909(Traditional)
ATTN: Shinji  Mori                PHONE NO : 81 3 37582111 
9-1, Imaikami-cho, Nakahara-ku    SE DECISION MADE: 27-JAN-17
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
HARTALEGA SDB. BHD.               510(k) NO: K162924(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 6 2771733 
DATARAN SD PJU9                   SE DECISION MADE: 24-JAN-17
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K162931(Abbreviated)
ATTN: Ruojuan  Zhang              PHONE NO : 31 631 685825 
VEENPLUIS 4-6                     SE DECISION MADE: 06-JAN-17
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ranfac Fat Aspiration Cannula
RANFAC CORP.                      510(k) NO: K162932(Traditional)
ATTN: CHRISTOPHER  WHELAN         PHONE NO : 508 5884400 
30 DOHERTY AVENUE, P.O. BOX 635   SE DECISION MADE: 19-JAN-17
Avon MA  02322                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8ch Knee-Foot SPEEDER
QUALITY ELECTRODYNAMICS, LLC      510(k) NO: K162946(Traditional)
ATTN: KATHLEEN  ARAS              PHONE NO : 440 4842964 
700 BETA DRIVE SUITE 100          SE DECISION MADE: 06-JAN-17
MAYFIELD VILLAGE OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
DIASORIN INC.                     510(k) NO: K162959(Special)
ATTN: JOHN  WALTER                PHONE NO : 651 4399710 
1951 NORTHWESTERN AVE.            SE DECISION MADE: 04-JAN-17
STILLWATER MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
DIASORIN INC.                     510(k) NO: K162961(Special)
ATTN: JOHN  WALTER                PHONE NO : 651 4399710 
1951 NORTHWESTERN AVE.            SE DECISION MADE: 05-JAN-17
STILLWATER MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthAlign Plus System
OrthAlign, Inc.                   510(k) NO: K162962(Traditional)
ATTN: David  Vancelette           PHONE NO : 949 7152424 
120 Columbia, Suite 500           SE DECISION MADE: 23-JAN-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
DiaSorin Inc.                     510(k) NO: K162969(Special)
ATTN: John  Walter                PHONE NO : 651 4399710 
1951 Northwestern Avenue          SE DECISION MADE: 06-JAN-17
Stillwater MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreludeSYNC Radial Compression Device
Merit Medical Systems, Inc.       510(k) NO: K162988(Traditional)
ATTN: Ileana  Davis               PHONE NO : 801 208 4187
1600 West Merit Parkway           SE DECISION MADE: 25-JAN-17
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radifocus Glidewire Advantage Track
Ashitaka Factory of Terumo Coporat510(k) NO: K163004(Traditional)
ATTN: Dina  Justice               PHONE NO : 732 4124166 
150 Maimaigi-cho                  SE DECISION MADE: 30-JAN-17
Fujinomiya Shizuoka  JP 418-0015  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
bioMerieux, Inc.                  510(k) NO: K163006(Traditional)
ATTN: Jennifer  Jines             PHONE NO : 314 7318352 
595 Anglum Rd.                    SE DECISION MADE: 24-JAN-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantib Brain 1.2
Quantib BV                        510(k) NO: K163013(Special)
ATTN: Rudolf  Scholte             PHONE NO : 31 108 4111749 
Westblaak 106                     SE DECISION MADE: 06-JAN-17
Rotterdam  NL 3012KM              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOS Small Bone Nailing System
Advanced Orthopaedic Solutions, In510(k) NO: K163014(Traditional)
ATTN: Alex  Bhaskarla             PHONE NO : 310 5339966 
3203 Kashiwa St.                  SE DECISION MADE: 24-JAN-17
Torrance CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
BIO-RAD LABORATORIES              510(k) NO: K163015(Traditional)
ATTN: ELIZABETH  PLATT            PHONE NO : 949 5981285 
9500 JERONIMO ROAD                SE DECISION MADE: 10-JAN-17
IRVINE CA  92618-2017             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: chromID Strepto B agar
bioMerieux, Inc.                  510(k) NO: K163042(Traditional)
ATTN: Karen  Russell              PHONE NO : 314 7318639 
595 Anglum Road                   SE DECISION MADE: 27-JAN-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOLOC® 3Di Ankle Fracture Plating System
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K163044(Traditional)
ATTN: Val  Myles                  PHONE NO : 901 2905162 
1023 CHERRY RD                    SE DECISION MADE: 26-JAN-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
BOSTON SCIENTIFIC                 510(k) NO: K163058(Traditional)
ATTN: Jennifer  Edouard           PHONE NO : 508 6836134 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 30-JAN-17
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K163069(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 19-JAN-17
Hachioji  JP 182-8507             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lifestyles Zero Lubricated Latex Male Condom
ANSELL HEALTHCARE PRODUCTS, LLC   510(k) NO: K163107(Abbreviated)
ATTN: Robert  Mahler              PHONE NO : 732 3452174 
111 Wood Avenue South, Suite 210  SE DECISION MADE: 23-JAN-17
Iselin NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K163113(Special)
ATTN: Patrick  Chow               PHONE NO : 852 28516789 
BLOCK 7, ZHU KENG INDUSTRIAL ZONE,SE DECISION MADE: 19-JAN-17
SHENZHEN  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire II PRO
OrbusNeich Medical Inc.           510(k) NO: K163114(Traditional)
ATTN: John  Pazienza              PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 05-JAN-17
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
Philips Medical Systems Nederland 510(k) NO: K163116(Abbreviated)
ATTN: Ruojuan  Zhang              PHONE NO : 31 63 1685825 
Veenpluis 4-6                     SE DECISION MADE: 06-JAN-17
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
Philips Ultrasound, Inc.          510(k) NO: K163120(Traditional)
ATTN: Peng  Cui                   PHONE NO : 978 6597966 
3000 Minuteman Road               SE DECISION MADE: 10-JAN-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelClinician, DTX Studio implant
NOBEL BIOCARE AB                  510(k) NO: K163122(Traditional)
ATTN: CHALEMAGNE  CHUA            PHONE NO : 714 2824800 7830
VASTRA HAMNGATAN 1                SE DECISION MADE: 31-JAN-17
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epic Pro
Biolase, Inc                      510(k) NO: K163128(Special)
ATTN: Alicia  Mszyca              PHONE NO : 949 2268471 
4 Cromwell                        SE DECISION MADE: 11-JAN-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAMIC ClearaCIL Contrast Injection Lines
AngioDynamics, Inc.               510(k) NO: K163141(Traditional)
ATTN: Teri  Juckett               PHONE NO : 518 7951142 
10 Glens Falls Technology Park    SE DECISION MADE: 06-JAN-17
Glens Falls NY  12801             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
ArthroCare Corporation            510(k) NO: K163142(Special)
ATTN: Laura  Kasperowicz          PHONE NO : 949 5852406 
15285 Alton Parkway Suite 200     SE DECISION MADE: 06-JAN-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
Materialise NV                    510(k) NO: K163156(Traditional)
ATTN: Oliver  Clemens             PHONE NO : 32 16 396280 
Technologielaan 15                SE DECISION MADE: 18-JAN-17
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
CAPILLUS, LLC                     510(k) NO: K163170(Traditional)
ATTN: PATRICIA  SCHNOOR           PHONE NO : 786 8881874 
1715 NW 82nd Avenue               SE DECISION MADE: 31-JAN-17
MIAMI FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exilis XP II
BTL Industries, Inc.              510(k) NO: K163176(Traditional)
ATTN: David  Chmel                PHONE NO : 866 2851656 
47 Loring Drive                   SE DECISION MADE: 12-JAN-17
Framingham MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Onli Intermittent Catheter
HOLLISTER INCORPORATED            510(k) NO: K163179(Special)
ATTN: JEANNE  LEE                 PHONE NO : 847 99663540 
2000 HOLLISTER DRIVE              SE DECISION MADE: 26-JAN-17
LIBERTYVILLE IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 48CH Head Coil
GE Healthcare Coils (USA Instrumen510(k) NO: K163205(Traditional)
ATTN: Mary A. Mayka               PHONE NO : 330 9955708 
1515 Danner Drive                 SE DECISION MADE: 12-JAN-17
Aurora OH  44202                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips CombiDiagnost R90
Philips Medical Systems DMC GmbH  510(k) NO: K163210(Traditional)
ATTN: Ming  Xiao                  PHONE NO : 49 40 50782306 
Roentgenstrasse 24-26             SE DECISION MADE: 31-JAN-17
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Sempra with syngo MR E11S
Siemens Medical Solutions USA, Inc510(k) NO: K163211(Traditional)
ATTN: Cordell L Fields            PHONE NO : 610 4486469 
65  Valley Steam Pkwy.            SE DECISION MADE: 27-JAN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Chameleon PTA Balloon Catheter
AV Medical Technologies Ltd       510(k) NO: K163231(Traditional)
ATTN: Limor  Sandach              PHONE NO : 972 77 5055645 
21b Habarzel Street               SE DECISION MADE: 17-JAN-17
Tel-Aviv  IL 6971029              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mammomat Fusion with Stereotactic Biopsy
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K163252(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 4486139 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 10-JAN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys Cardio DL
ARTERYS INC.                      510(k) NO: K163253(Traditional)
ATTN: Golnaz  Moeini              PHONE NO : 408 5043187 
51 FEDERAL ST. SUITE 305          SE DECISION MADE: 05-JAN-17
SAN FRANCISCO CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc.             510(k) NO: K163254(Traditional)
ATTN: James A Bonafini            PHONE NO : 585 458 8409
1667 Lake Avenue, Suite 354       SE DECISION MADE: 18-JAN-17
Rochester NY  14615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossFT Knotless Suture Anchor with Disposable Driver
ConMed Corporation                510(k) NO: K163258(Special)
ATTN: Nyrobia  Freeman            PHONE NO : 727 3995416 
525 French Road                   SE DECISION MADE: 25-JAN-17
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RP Lite 760R
Mego Afek AC Ltd.                 510(k) NO: K163280(Special)
ATTN: Ilan  Sharon                PHONE NO : 972 77 9084276 
Kibbutz Afek                      SE DECISION MADE: 27-JAN-17
Kibbutz Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: FastStroke
GEf Medical Systems SCS           510(k) NO: K163281(Traditional)
ATTN: Kristine  Schraufnagel      PHONE NO : 262 3127344 
283 rue de la Miniere             SE DECISION MADE: 26-JAN-17
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaBone IRM
NovaBone Products, LLC            510(k) NO: K163310(Traditional)
ATTN: Gregory  Pomrink            PHONE NO : 386 4621010 
13510 NW US Highway 441           SE DECISION MADE: 18-JAN-17
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
Siemens Medical Solutions USA, Inc510(k) NO: K163312(Traditional)
ATTN: Cordell L Fields            PHONE NO : 610 4486469 
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 27-JAN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nordicBrainEx
NordicNeurolab AS                 510(k) NO: K163324(Traditional)
ATTN: CHANDANA GURUNG BHANDARI    PHONE NO : 47 557 07095 
MOLLENDALSVEIEN 65C               SE DECISION MADE: 27-JAN-17
BERGEN  NO N-5009                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FITBONE TAA
WITTENSTEIN intens GmbH           510(k) NO: K163368(Traditional)
ATTN: Hartmut  Kampa              PHONE NO : 49 7931 49310485 
Walter-Wittensstein-StraBe 1      SE DECISION MADE: 26-JAN-17
Igersheim  DE 97999               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON P500 Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K163396(Third Party - Traditional)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 East Middlefield Road         SE DECISION MADE: 04-JAN-17
Moutain View CA  94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Isolator Multifunctional Linear Pen
AtriCure Inc.                     510(k) NO: K163408(Special)
ATTN: Melissa  Smallwood          PHONE NO : 513 6444736 
7555 Innovation Way               SE DECISION MADE: 03-JAN-17
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigitalDiagnost C50
PHILIPS HEALTHCARE (SUZHOU) CO., L510(k) NO: K163410(Special)
ATTN: ALINA  ZHOU                 PHONE NO : 86 512 67336582 
NO. 258, ZHONG YUAN ROAD SUZHOU INSE DECISION MADE: 04-JAN-17
SUZHOU  CN 215024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.via MI Workflows
Siemens Medical Solutions USA, Inc510(k) NO: K163421(Special)
ATTN: Veronica  Padharia          PHONE NO : 630 8775761 
810 Innovation Drive              SE DECISION MADE: 03-JAN-17
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
United State Endoscopy Group, Inc.510(k) NO: K163424(Special)
ATTN: Ganga  Kolli                PHONE NO : 440 3586261 
5976 Heisley Rd.                  SE DECISION MADE: 04-JAN-17
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP.           510(k) NO: K163427(Special)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f, yizhe bSE DECISION MADE: 03-JAN-17
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B6
Beijing East Whale Imaging Technol510(k) NO: K163429(Traditional)
ATTN: Sharon  Fan                 PHONE NO : 86 10 67892701 8058
Unit701, Building1, Yongchang InduSE DECISION MADE: 04-JAN-17
Beijing  CH 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectre guidewire
Vascular Solutions, Inc.          510(k) NO: K163444(Special)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 06-JAN-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
ETHICON ENDO-SURGERY, LLC         510(k) NO: K163454(Special)
ATTN: Carmen  Ortiz               PHONE NO : 787 2726500 6144
475 CALLE C                       SE DECISION MADE: 05-JAN-17
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DuraGen Secure Dural Regeneration Matrix
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K163456(Special)
ATTN: YARA  HAMID                 PHONE NO : 609 9366858 
311 ENTERPRISE DRIVE              SE DECISION MADE: 06-JAN-17
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuraGen 3D Nerve Guide Matrix
Integra LifeSciences Corporation  510(k) NO: K163457(Special)
ATTN: Gabriella  Green            PHONE NO : 609 2162970 
311 Enterprise Drive              SE DECISION MADE: 06-JAN-17
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2P Metacross RX
KANEKA CORPORATION                510(k) NO: K163479(Special)
ATTN: TOSHIHIKO  MOTOMINE         PHONE NO : 81 355 748023 
1-12-32, AKASAKA, MINATO-KU       SE DECISION MADE: 11-JAN-17
TOKYO  JP 107-6028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StatStrip Xpress 2 Glucose Hospital Meter System
Nova Biomedical Corporation       510(k) NO: K163490(Special)
ATTN: Paul W. MacDonald           PHONE NO : 781 6473700 
200 Prospect Street               SE DECISION MADE: 06-JAN-17
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
United states Endoscopy Group, Inc510(k) NO: K163492(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 06-JAN-17
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: RX DC
CEFLA SC                          510(k) NO: K163519(Traditional)
ATTN: BORTOLOTTI  LORENZO         PHONE NO : 39 054 2653441 
VIA SELICE PROV. LE 23/A          SE DECISION MADE: 13-JAN-17
IMOLA  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G LH Calibrators
FUJIREBIO DIAGNOSTICS, INC        510(k) NO: K163521(Abbreviated)
ATTN: DIANA  DICKSON              PHONE NO : 610 2403917 
201 GREAT VALLEY PARKWAY          SE DECISION MADE: 12-JAN-17
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzDent-i; E2; ProraView
EWOO SOFT CO., LTD.               510(k) NO: K163533(Special)
ATTN: YOUNG SEOK KIM              PHONE NO : 82 318 0156171 
801-HO, VATECHNETWORKS BLDG 13, SASE DECISION MADE: 12-JAN-17
HWASEONG-SI  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G FSH-N Calibrators
Fujirebio Diagnostics, Inc.       510(k) NO: K163534(Abbreviated)
ATTN: Diana  Dickerson            PHONE NO : 610 2403917 
201 Great Valley Parkway          SE DECISION MADE: 13-JAN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magseed Magnetic Marker System
ENDOMAGNETICS LTD                 510(k) NO: K163541(Special)
ATTN: ANDREW  SHAWCROSS           PHONE NO : 44 012 230652540 
THE JEFFREYS BUILDING COWLEY ROAD SE DECISION MADE: 13-JAN-17
CAMBRIDGE  GB CB4 0WS             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
Datascope Corp.                   510(k) NO: K163542(Special)
ATTN: Helder A. Sousa             PHONE NO : 973 7097465 
1300 MacArthur Blvd.              SE DECISION MADE: 31-JAN-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G Prolactin
FUJIREBIO DIAGNOSTICS, INC.       510(k) NO: K163544(Abbreviated)
ATTN: STACEY  DOLAN               PHONE NO : 610 2403843 
201 GREAT VALLEY PARKWAY          SE DECISION MADE: 12-JAN-17
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G Progesterone-N Calibrators
Fujirebio Diagnostics, Inc.       510(k) NO: K163546(Abbreviated)
ATTN: Stacey  Dolan               PHONE NO : 610 2403843 
201 Great Valley Parkway          SE DECISION MADE: 13-JAN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
Immunostics, Inc.                 510(k) NO: K163554(Special)
ATTN: Antoinette  Prusik          PHONE NO : 732 9180770 
1750 Brielle Ave., AS             SE DECISION MADE: 17-JAN-17
Ocean NJ  07712                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi Modality Viewer
Vital Images, Inc.                510(k) NO: K163574(Traditional)
ATTN: Susan  Atwood               PHONE NO : 952 4879759 
5850 Opus Parkway Suite 300       SE DECISION MADE: 26-JAN-17
Minnetonka ME  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEDEX WL070+
DENTMATE TECHNOLOGY CO., LTD.     510(k) NO: K163605(Special)
ATTN: CHENG-FENG  CHOU            PHONE NO : 886 2 89769226 
8F, No.8-11, Sec.1, Zhongxing RoadSE DECISION MADE: 19-JAN-17
New Taipei  TW 24872              510(k) STATEMENT
                                                    

DEVICE: Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
Covidien                          510(k) NO: K163620(Special)
ATTN: Nicole  Genco               PHONE NO : 508 4524128 
15 Hampshire Stree                SE DECISION MADE: 19-JAN-17
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
Siemens Medical Solutions USA, Inc510(k) NO: K163635(Third Party - Traditional)
ATTN: Sulgue  Choi                PHONE NO : 425 2819898 
685 East Middlefield Road         SE DECISION MADE: 12-JAN-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Quantum Workstation
Spectrum Medical Ltd              510(k) NO: K163657(Special)
ATTN: Mark  Drain                 PHONE NO : 440 1242 650120 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 18-JAN-17
Gloucester  GB GL2 9QL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantera LEO
BIOTRONIK, INC.                   510(k) NO: K163660(Special)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 JEAN ROAD                    SE DECISION MADE: 26-JAN-17
LAKE OSWEGO OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Clear Tray Aligner
3M Unitek Corporation             510(k) NO: K163689(Third Party - Traditional)
ATTN: Yanine  Garcia-Quezada      PHONE NO : 651 7368238 
2724 South Peck Road              SE DECISION MADE: 27-JAN-17
Monrovia CA  91016                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IntraClude Intra-Aortic Occlusion Device
Edwards Lifesciences LLC          510(k) NO: K163693(Special)
ATTN: Lisa G. Hessabi             PHONE NO : 949 2506384 
One Edwards Way                   SE DECISION MADE: 26-JAN-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzRay Air W
Vatech Co., Ltd                   510(k) NO: K163705(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 24-JAN-17
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allura Xper R9
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K163715(Special)
ATTN: JEANETTE  BECKER            PHONE NO : 31 611 386380 
VEENPLUIS 4-6                     SE DECISION MADE: 26-JAN-17
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nvc
Nvision Biomedical Technologies, L510(k) NO: K170074(Special)
ATTN: Diana L Langham             PHONE NO : 210 5453713 
1350 N Loop 1604 E, Suite 103     SE DECISION MADE: 24-JAN-17
San Antonio TX  78232             510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   222                                     
         TOTAL WITH SUMMARIES        203                                     
         TOTAL WITH STATEMENTS        19