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  1. 510(k) Clearances

August 2017 510(k) Clearances

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


DEVICE: Glucommander
GLYTEC, LLC                       510(k) NO: K152300(Traditional)
ATTN: JULIE  GLENDRANGE           PHONE NO : 864 2634180 
770 PELHAM ROAD, SUITE 210        SE DECISION MADE: 04-AUG-17
GREENVILLE SC  29615              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
BRH Medical Ltd.                  510(k) NO: K160378(Traditional)
ATTN: Kevin  Bentley              PHONE NO : 972 02 6483519 
The Jerusalem Technological GardenSE DECISION MADE: 25-AUG-17
Jerusalem  IL 96951               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nucleoss Tpure Implant System
SANLILAR TIBBI CIHAZLAR MED. KIM.S510(k) NO: K160850(Traditional)
ATTN: EZGI  ERDEM                 PHONE NO : 90 232 7990304 
10018 SOK. NO 7 ITOB ORGANIZE SANASE DECISION MADE: 04-AUG-17
BOLGESI TEKELI  TR TR-35477       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: "Paonan" Armstrong Posterior Spinal Fixation System
Paonan Biotech Co., Ltd.          510(k) NO: K161225(Traditional)
ATTN: YI-JHEN  TSAI               PHONE NO : 886 2 26274366 
3F, NO.50, LANE 258, RUEIGUANG RD.SE DECISION MADE: 11-AUG-17
TAIPEI  TW 11491                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ShenDa Sinuscope
SHENYANG SHENDA ENDOSCOPE CO., LTD510(k) NO: K161298(Traditional)
ATTN: GAO  FENG                   PHONE NO : 86 24 88093290 
NO.123 HEZUO STREET, DADONG DISTRISE DECISION MADE: 25-AUG-17
SHENYANG  CN 110044               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
SURGICAL INSTRUMENT SERVICE AND SA510(k) NO: K161358(Traditional)
ATTN: BRANDI J. PANTELEON         PHONE NO : 541 9233310 
2747 SW 6TH ST.                   SE DECISION MADE: 03-AUG-17
REDMOND OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s LDL-EX "SEIKEN"
DENKA SEIKEN CO., LTD.            510(k) NO: K161679(Traditional)
ATTN: Takayoshi  Ishii            PHONE NO : 81 250 420721 
1359-I, Kagamida, Kigoshi         SE DECISION MADE: 18-AUG-17
Gosen  JP 959-1695                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
SUMMIT MEDICAL PRODUCTS, INC      510(k) NO: K162165(Traditional)
ATTN: LeVoy  Haight               PHONE NO : 801 4170463 
504 West 8360 South               SE DECISION MADE: 29-AUG-17
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arzzt 3.5 / 4.5 Small & Large Fragments System
TRUEMED GROUP, LLC                510(k) NO: K162507(Traditional)
ATTN: Jorge  Castillo             PHONE NO : 1 713 8583189 
20507 NANNETTE LN                 SE DECISION MADE: 03-AUG-17
SPRINT TX  77388                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kelowna GYN and Crook Prostate Templates
Varian Medical Systems, Inc       510(k) NO: K162533(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246230 
3100 Hansen Way                   SE DECISION MADE: 31-AUG-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
SIEMENS HEALTHCARE DIAGNOSTICS PRO510(k) NO: K162540(Traditional)
ATTN: ROSE T MARINELLI            PHONE NO : 302 6318805 
EMIL-VON BEHRING STR 76           SE DECISION MADE: 22-AUG-17
MARBURG  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reverse Pull Adjustable Facemask
SAWBROS INDUSTRIES PVT.LTD.       510(k) NO: K162543(Traditional)
ATTN: DHRUV  SAWHNEY              PHONE NO : 91 99 11117584 
A-68 SECTOR 2                     SE DECISION MADE: 28-AUG-17
NOIDA  IN 201301                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integrated Catch-up Freedom Syringe Driver Infusion System
Repro-Med Systems, Inc., DBA RMS M510(k) NO: K162613(Traditional)
ATTN: Fred  Ma                    PHONE NO : 845 4692042 
24 Carpenter Road                 SE DECISION MADE: 31-AUG-17
Chester NY  10918                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
COOK INCORPORATED                 510(k) NO: K162729(Traditional)
ATTN: KOTEI  AOKI                 PHONE NO : 812 3353575 102630
750 DANIELS WAY, P.O. BOX 489     SE DECISION MADE: 11-AUG-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Everyway OTC EMS, Model EV-805
EVERYWAY MEDICAL INSTRUMENT CO., L510(k) NO: K162744(Traditional)
ATTN: PAUL  HUNG                  PHONE NO : 886 2 2662038 
3FL., NO. 5, LANE 155, SECTION 3, SE DECISION MADE: 03-AUG-17
SHENKENG DIST, NEW TAIPEI CITY  TW510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
INTEGRAL PROCESS SAS              510(k) NO: K162768(Abbreviated)
ATTN: Virginie S Grondin          PHONE NO : 33 1 39726666 
12 RUE DES CAYENNES PO BOX BP 2031SE DECISION MADE: 16-AUG-17
CONFLANS SAINTE HONORINE  FR 78703510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 731 Series Ventilators
ZOLL MEDICAL CORPORATION          510(k) NO: K162832(Traditional)
ATTN: CHUCK  KOLIFRATH            PHONE NO : 978 4219171 
269 & 271 MILL ROAD               SE DECISION MADE: 02-AUG-17
CHELMSFORD MA  01824-4105         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allerhope Allergy Skin Tester
PROCARE INDUSTRIAL CO., LIMITED   510(k) NO: K162917(Traditional)
ATTN: WANG  YANHONG               PHONE NO : 86 136 73363790 
NO.5-2-9-160, SCIENCE AVENUE 89 HISE DECISION MADE: 17-AUG-17
ZHENGZHOU  CN 450000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyMRI
SyntheticMR AB                    510(k) NO: K162943(Traditional)
ATTN: Maria  Almesaker            PHONE NO : 460 70 4151007 
Storgatan 11                      SE DECISION MADE: 29-AUG-17
Linkoping  SE 582 23              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
KERR CORPORATION                  510(k) NO: K162948(Traditional)
ATTN: Jennifer  Dzidrums          PHONE NO : 909 9625650 
1717 W. COLLINS AVE.              SE DECISION MADE: 08-AUG-17
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA 2120i, ADVIA 2120
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K162977(Traditional)
ATTN: Gerard  Sadrakula           PHONE NO : 914 5242582 
511 BENEDICT AVENUE               SE DECISION MADE: 11-AUG-17
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartUs EXT-1M/3M
TELEMED                           510(k) NO: K163121(Traditional)
ATTN: YURY  SOKOLOV               PHONE NO : 370 521 06272 
DARIAUS IR GIRENO STR.42          SE DECISION MADE: 10-AUG-17
VILNIUS  LT LT-02189              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
IMMCO Diagnostics, Inc.           510(k) NO: K163133(Traditional)
ATTN: Kevin  Lawson               PHONE NO : 716 4915452 
9870 Hollingson Rd.               SE DECISION MADE: 08-AUG-17
Clarence NY  14031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
EASYWELL BIOMEDICALS, INC.        510(k) NO: K163166(Traditional)
ATTN: ARTHUR  CHEN                PHONE NO : 886 366 69596 
SUITE 2, 2F, NO.9, JHANYE 1 RD. HSSE DECISION MADE: 11-AUG-17
Hsinchu  TW                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CKS Plus Knee System
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K163167(Traditional)
ATTN: ZAC  JOHNSON                PHONE NO : 916 3557100 
1115 WINDFIELD WAY                SE DECISION MADE: 09-AUG-17
EL DORADO HILLS CA  95762         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AFIAS iFOB with AFIAS-50
IMMUNOSTICS, INC.                 510(k) NO: K163225(Traditional)
ATTN: Antoinette  Prusik          PHONE NO : 800 7227505 
1750 BRIELLE AVENUE, A5           SE DECISION MADE: 08-AUG-17
OCEAN NJ  07712                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Essence Universal Porcelain System
BLUE SKY BIO                      510(k) NO: K163251(Traditional)
ATTN: ALBERT  ZICKMANN            PHONE NO : 718 3760422 
888 E BELVEDERE RD SUITE 212      SE DECISION MADE: 04-AUG-17
GRAYSLAKE IL  60030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
ROCKET MEDICAL PLC                510(k) NO: K163321(Traditional)
ATTN: Tracy  Charlton             PHONE NO : 0044 191 4194488 222
2-4 SEDLING RD, WEAR INDUSTRIAL ESSE DECISION MADE: 17-AUG-17
WASHINGTON  GB NE38 9BZ           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
Midmark Corporation               510(k) NO: K163337(Traditional)
ATTN: ADAM  CLUTTER               PHONE NO : 937 5268474 
60 VISTA DR.                      SE DECISION MADE: 31-AUG-17
VERSAILLES OH  45380              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
SPECTRALMD, INC.                  510(k) NO: K163339(Traditional)
ATTN: J. MICHAEL DIMAIO           PHONE NO : 972 4994934 
2515 MCKINNEY AVENUE              SE DECISION MADE: 17-AUG-17
DALLAS TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT Hematocrit test with i-STAT Alinity System
Abbott Laboratories               510(k) NO: K163342(Traditional)
ATTN: Tamara  McCaw               PHONE NO : 613 6885949 2331
400 College Road East             SE DECISION MADE: 22-AUG-17
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARK Methotrexate Assay
ARK Diagnostics, Inc.             510(k) NO: K163359(Special)
ATTN: Cherry  Mun                 PHONE NO : 510 2706288 
48089 Fremont Boulevard           SE DECISION MADE: 18-AUG-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenetiSure Dx Postnatal Assay
Agilent Technologies, Inc.        510(k) NO: K163367(Traditional)
ATTN: Lois  Nakayama              PHONE NO : 408 5532715 
5301 Stevens Creek Blvd.          SE DECISION MADE: 11-AUG-17
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFINITY™ OCT System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K163375(Traditional)
ATTN: Tejas  Patel                PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 21-AUG-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cortex Dental Implant System
Cortex Dental Implants Industries 510(k) NO: K163385(Traditional)
ATTN: Michal  Yeger               PHONE NO : 972 4 9873970 
Shlomi Industrial Estate          SE DECISION MADE: 29-AUG-17
Shlomi  IL 22832                  510(k) STATEMENT
                                                    

DEVICE: iC-GPC Assay TM for use on the iC-SystemTM
iCubate, Inc                      510(k) NO: K163390(Traditional)
ATTN: Carter  Wells               PHONE NO : 256 8813692 
601 Genome Way                    SE DECISION MADE: 08-AUG-17
Huntsville AL  35806              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hi-Dow Wireless TENS/EMS System (Model HD-SN)
Hi-Dow International, Inc.        510(k) NO: K163393(Traditional)
ATTN: Eric  Chen                  PHONE NO : 314 5692888 
2555 Metro Blvd                   SE DECISION MADE: 04-AUG-17
Maryland Heights MO  63043        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATLANTIS suprastructures
Dentsply Sirona                   510(k) NO: K163398(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 14-AUG-17
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NLZ Motor System
NAKANISHI INC.                    510(k) NO: K163402(Traditional)
ATTN: Kimihiko  Satoh             PHONE NO : 81 289 644325 
700 Shimohinata                   SE DECISION MADE: 31-AUG-17
Kanuma-shi  JP 322-8666           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme DZ-Lite Total beta-hCG Test System
Diazyme Laboratories              510(k) NO: K163418(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 18-AUG-17
Poway CA  92130                   510(k) STATEMENT
                                                    

DEVICE: Orthopantomograph OP300
PaloDEx Group Oy                  510(k) NO: K163423(Traditional)
ATTN: Eric  Schwandt              PHONE NO : 358 10 2702000 
Nahkelantie 160                   SE DECISION MADE: 31-AUG-17
Tuusula  FI FI-04300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Locking Cage, Full XPE Cup
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K163441(Traditional)
ATTN: GIMPEL  CHIEN               PHONE NO : 886 357 73351 2217
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 25-AUG-17
HSINCHU  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxoGen Nerve Cap
AxoGen Corporation                510(k) NO: K163446(Traditional)
ATTN: Mark L. Friedman            PHONE NO : 386 4626800 
13631 Progress Blvd               SE DECISION MADE: 08-AUG-17
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Blood Pressure Monitor
Portal 724, LLC                   510(k) NO: K163473(Traditional)
ATTN: George  Oneid               PHONE NO : 855 5365724 
275 Hartz Way Suite 105           SE DECISION MADE: 29-AUG-17
Secaucus NJ  07094                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PANA SPRAY Plus
NAKANISHI, INC.                   510(k) NO: K163483(Traditional)
ATTN: Kimihiko  Satoh             PHONE NO : 81 0289 643380 
700 Shimohinata                   SE DECISION MADE: 15-AUG-17
Kanuma-shi  JP 322-8666           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartTouch
Adherium (NZ) Ltd                 510(k) NO: K163485(Traditional)
ATTN: CHRIS  MANDER               PHONE NO : 64 930 72771 
Level 2, 204 Quay Street          SE DECISION MADE: 30-AUG-17
Auckland  NZ 1010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
Ion Beam Applications S.A.        510(k) NO: K163500(Traditional)
ATTN: Anne-Sophie  Grell          PHONE NO : 0032 10 475816 
Chemin du Cyclotron, 3            SE DECISION MADE: 17-AUG-17
Louvain-la-Neuve  BE 1348         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SHOFU RESIN GLAZE
Shofu Dental Corporation          510(k) NO: K163568(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 Stone Drive                  SE DECISION MADE: 16-AUG-17
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
Carolina Liquid Chemistries Corpor510(k) NO: K163570(Traditional)
ATTN: Mica A. Welsh               PHONE NO : 877 7228910 
575 North Patterson Avenue, Suite SE DECISION MADE: 15-AUG-17
Winston-Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System
Signature Orthopaedics Pty Ltd.   510(k) NO: K163625(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 11-AUG-17
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Idylla Respiratory (IFV-RSV) Panel
JANSSEN PHARMACEUTICA NV          510(k) NO: K163628(Traditional)
ATTN: SARAH  PARSONS              PHONE NO : 32 146 03566 
TURNHOUTSEWEG 30                  SE DECISION MADE: 30-AUG-17
BEERSE  BE 2340                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolve Envi 600 Advanced Adipose System
LifeCell Corporation              510(k) NO: K163647(Traditional)
ATTN: Anuja  Yardi                PHONE NO : 908 9471100 
One Millennium Way                SE DECISION MADE: 25-AUG-17
Branchburg NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Borrelia B31 ViraChip IgM Test Kit
Viramed Biotech AG                510(k) NO: K163695(Traditional)
ATTN: Martin  Kintrup             PHONE NO : 49 89 899336 
Behringstrasse 11                 SE DECISION MADE: 22-AUG-17
Planegg  DE 82152                 510(k) STATEMENT
                                                    

DEVICE: Zip 4 Skin Closure Device
ZipLine Medical, Inc.             510(k) NO: K170003(Traditional)
ATTN: Trish  Howell               PHONE NO : 408 6840753 
747 Camden Ave, Suite A           SE DECISION MADE: 18-AUG-17
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Salle Intraoperative Pyeloplasty Stent Set
COOK INCORPORATED                 510(k) NO: K170010(Traditional)
ATTN: MINJIN  CHOI                PHONE NO : 812 3392235 104901
750 DANIELS WAY                   SE DECISION MADE: 28-AUG-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Internal Octa Implant System
EBI Inc.                          510(k) NO: K170031(Traditional)
ATTN: Mi Sook Kim                 PHONE NO : 82 53 8177767 
124, Uisong-gil, Amnyang-myeon    SE DECISION MADE: 31-AUG-17
Gyeongsan-si  KR 38493            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Breathe Technologies Life2000™ Ventilation System
Breathe Technologies              510(k) NO: K170037(Traditional)
ATTN: Samir  Ahmad                PHONE NO : 949 9887724 
175 Technology Drive, Suite 100   SE DECISION MADE: 11-AUG-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FuzeFix Screw System
Fusion Orthopedics, LLC           510(k) NO: K170038(Traditional)
ATTN: Adam  Cundiff               PHONE NO : 800 4036876 
4135 S. Power Rd. Suite 110       SE DECISION MADE: 07-AUG-17
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M22 and ResurFx Systems
LUMENIS, LTD.                     510(k) NO: K170060(Special)
ATTN: Naama  Jacoby               PHONE NO : 972 4 9599085 
6 HAKIDMA STREET PO Box 240       SE DECISION MADE: 09-AUG-17
YOKNEAM  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLUCOCARD W Blood Glucose Monitoring System
ARKRAY FACTORY, INC.              510(k) NO: K170064(Traditional)
ATTN: KAZUYA  YORIMITSU           PHONE NO : 81 748 866901 
1480 KOJI, KONAN-CHO              SE DECISION MADE: 16-AUG-17
KOKA-SHI  JP 520-3306             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reperen Surgical Mesh
IconLab Inc.                      510(k) NO: K170134(Traditional)
ATTN: Pavel Paul Artemow          PHONE NO : 949 3307190 
65 Enterprise                     SE DECISION MADE: 09-AUG-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
SHANDONG FEIYANG PROFESSIONAL GLOV510(k) NO: K170136(Traditional)
ATTN: KEN  LU                     PHONE NO : 86 133 55336830 
338 HUAQING DRIVE QIXIN CHEMICAL ISE DECISION MADE: 25-AUG-17
QINGZHOU  CN 255000               510(k) STATEMENT
                                                    

DEVICE: 3DMetal Tibial Cones
Medacta International SA          510(k) NO: K170149(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 18-AUG-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid Tox Cup II
AMERICAN BIO MEDICA CORP.         510(k) NO: K170222(Traditional)
ATTN: MELISSA  WATERHOUSE         PHONE NO : 800 2271243 
122 SMITH ROAD                    SE DECISION MADE: 15-AUG-17
KINDERHOOK NY  12106              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruMatch CMF Titanium 3D Printed Implant System
Materialise NV                    510(k) NO: K170272(Traditional)
ATTN: Lina  Ramirez               PHONE NO : 32 16 396280 
Technologielaan 15                SE DECISION MADE: 08-AUG-17
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AED Sinuscope
National Advanced Endoscopy Device510(k) NO: K170285(Traditional)
ATTN: Gayle  Butler               PHONE NO : 818 2272720 
22134 Sherman Way                 SE DECISION MADE: 01-AUG-17
Canoga Park CA  91303             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Comply Hydrogen Peroxide Chemical Indicator 1248
3M COMPANY                        510(k) NO: K170321(Traditional)
ATTN: NADIA  BATTAH               PHONE NO : 651 7330929 
3M CENTER BUILDING 275-5W-06      SE DECISION MADE: 14-AUG-17
ST.PAUL MN  55144                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
Fisher and Paykel Healthcare Limit510(k) NO: K170367(Traditional)
ATTN: Danica  Tung                PHONE NO : 64 9 5740100 
15 Maurice Paykel Place           SE DECISION MADE: 24-AUG-17
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentium NR Line CAD/CAM Abutments
Dentium Co., Ltd.                 510(k) NO: K170384(Abbreviated)
ATTN: Sangpil  Yoon               PHONE NO : 82 31 2072200 
150, Eondong-ro, Giheung-gu       SE DECISION MADE: 17-AUG-17
Yongin-si  KR 16985               510(k) STATEMENT
                                                    

DEVICE: CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
Coeur, Inc.                       510(k) NO: K170431(Traditional)
ATTN: Priscilla  Clinner          PHONE NO : 615 5477923 
100 Physicians Way                SE DECISION MADE: 18-AUG-17
Lebanon TN  37090                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K170467(Traditional)
ATTN: Gerhard  Frick              PHONE NO : 41 71 7277059 
Espenstrasse 139                  SE DECISION MADE: 30-AUG-17
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
Surge Cardiovascular              510(k) NO: K170488(Traditional)
ATTN: Rick  Shorey                PHONE NO : 269 6290300 
(Alliant Enterprises DBA Surge CarSE DECISION MADE: 10-AUG-17
Grand Rapids MI  49504            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: xTAG CYP2D6 Kit v3
Luminex Molecular Diagnostics, Inc510(k) NO: K170492(Special)
ATTN: Jennifer  Grimes            PHONE NO : 416 5934323 42281
439 University Ave.               SE DECISION MADE: 11-AUG-17
Toronto  CA M5G 1Y8               510(k) STATEMENT
                                                    

DEVICE: Delight, Delight ortho, B&Lite S
DENTALL Co., Ltd.                 510(k) NO: K170529(Traditional)
ATTN: Jonghyuk  Lee               PHONE NO : 82 32 3276026 
301-905, Bucheontechnopark, 345, SSE DECISION MADE: 08-AUG-17
Bucheon-si  KR 14501              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ureteral Dilators and Percutaneous Nephrostomy Dilators
Coloplast Corp                    510(k) NO: K170531(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 17-AUG-17
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U Deliver Bolink ENFit Enteral Feeding Sets
U Deliver Medical, LLC            510(k) NO: K170555(Traditional)
ATTN: Brian  Johnson              PHONE NO : 612 3817330 
10150 City Walk Drive, Suite A    SE DECISION MADE: 17-AUG-17
Woodbury MN  55129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyndMove System, MyndMove Functional Electrical Stimulator
MyndTec Inc                       510(k) NO: K170564(Traditional)
ATTN: Alexa  Granger              PHONE NO : 1 909 3630564 222
2233 Argentia Road Suite 307      SE DECISION MADE: 30-AUG-17
Mississauga  CA l5n 2x7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
LifeWatch Services, Inc           510(k) NO: K170565(Traditional)
ATTN: Stefanie  Martinez-Koenig   PHONE NO : 224 2235443 
10255 W Higgins Road Suite 100    SE DECISION MADE: 01-AUG-17
Rosemont IL  60018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diacap Pro Dialyzer
B. Braun Avitum AG                510(k) NO: K170574(Traditional)
ATTN: Giuliana  Gavioli           PHONE NO : 39 0535 616757 
Am Buschberg 1                    SE DECISION MADE: 11-AUG-17
Melsungen  DE D-34212             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DESS Dental Smart Solutions
Terrats Medical SL                510(k) NO: K170588(Traditional)
ATTN: Roger  Terrats              PHONE NO : 34 93 5646006 
Avenida La Ferreria (Pol Ind FerreSE DECISION MADE: 08-AUG-17
Montcada i Reixac  ES 08110       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SureFlo EVD Catheter
Arkis BioSciences Inc.            510(k) NO: K170599(Traditional)
ATTN: Joseph  Howell              PHONE NO : 844 2475383 
1059 N. Cedar BluffRD #157        SE DECISION MADE: 31-AUG-17
Knoxville TN  37923               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TalarLift STS
Fusion Orthopedics, LLC           510(k) NO: K170624(Traditional)
ATTN: Adam  Cundiff               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 11-AUG-17
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRAVITY™ Soft Tissue Repair System
Wright Medical Technology, Inc.   510(k) NO: K170642(Traditional)
ATTN: Michael  Mullins            PHONE NO : 901 8674142 
1023 Cherry Road                  SE DECISION MADE: 22-AUG-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
Yangzhou Medline Industry Co., Ltd510(k) NO: K170651(Traditional)
ATTN: Jianzhong  Qi               PHONE NO : 86 514 87525631 
No. 108, Jinshan Road, Economic DeSE DECISION MADE: 02-AUG-17
Yangzhou  CN 225000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QEVO System with KINEVO 900
Carl Zeiss Meditec AG             510(k) NO: K170667(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 7364 206985 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 18-AUG-17
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accutorr 7/VS-900 Vital Signs Monitor
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K170712(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Building, Keji 12th Road SSE DECISION MADE: 02-AUG-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Moxxly Flow Collection System
Moxxly, Inc.                      510(k) NO: K170722(Traditional)
ATTN: Cara  Delzer                PHONE NO : 650___ 8143306 
1777 Yosemite Ave. Suite 235      SE DECISION MADE: 28-AUG-17
San Francisco CA  94124           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode Diolaze XL
InMode MD Ltd.                    510(k) NO: K170738(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 49 097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 07-AUG-17
Yokneam  IL 2066509               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Brainlab AG                       510(k) NO: K170750(Traditional)
ATTN: Rainer  Birkenbach          PHONE NO : 0049 89 9915680 
Olof-Palme-Str.9                  SE DECISION MADE: 24-AUG-17
Munchen  DE 81829                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Foot System (2.3/2.8)
Jeil Medical Corporation          510(k) NO: K170780(Traditional)
ATTN: Yein  Han                   PHONE NO : 82 850 3934 
#702, Kolon Science Valley 2nd 55,SE DECISION MADE: 14-AUG-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline UNITE® Snap-Off Screws
Medline Industries, Inc.          510(k) NO: K170782(Special)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
Three Lakes Drive                 SE DECISION MADE: 18-AUG-17
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powered Wheelchair DYW30A(D09)
Nanjing Jin Bai He Medical Apparat510(k) NO: K170787(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 86 25 85780699 
No. 61 Qinhuai Road, Jiangning EcoSE DECISION MADE: 09-AUG-17
Nanjing  CN 211106                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive LessRay with Enhanced Tracking
NuVasive, Incorporated            510(k) NO: K170800(Traditional)
ATTN: Manthan J. Damani           PHONE NO : 1 858 4582272 
7475 Lusk Boulevard               SE DECISION MADE: 18-AUG-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SnoreRx
Apnea Sciences Corporation        510(k) NO: K170825(Abbreviated)
ATTN: James  Fallon               PHONE NO : 1 949 6802771 
27121 Aliso Creek Road, Bldg 140  SE DECISION MADE: 18-AUG-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRACEPT Intraosseous Nerve Ablation System
Relievant Medsystems              510(k) NO: K170827(Traditional)
ATTN: Alex  DiNello               PHONE NO : 650 3681000 
2688 Middlefield Road, Suite A    SE DECISION MADE: 09-AUG-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniMAX
Medacta International SA          510(k) NO: K170845(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 08-AUG-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anterior Spine Truss System (STS) Interbody Fusion Device
4Web, Inc.                        510(k) NO: K170851(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 2857090 
6170 Research Rd. Suite 219       SE DECISION MADE: 07-AUG-17
Frisco TX  75033                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premier
Shandong Weigao Orthopaedic Device510(k) NO: K170861(Traditional)
ATTN: Han  Wang                   PHONE NO : 86 631 5788966 
No. 26 Xiangjiang Road, Tourist ReSE DECISION MADE: 04-AUG-17
Weihai  CN 264203                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aisys CS2
Datex-Ohmeda, Inc.                510(k) NO: K170872(Traditional)
ATTN: Michelle  Huettner          PHONE NO : 608 7093384 
3030 Ohmeda Drive PO Box 7550     SE DECISION MADE: 15-AUG-17
Madison WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Passport Series Patient Monitors(Passport 12m, Passport 17m)
Shenzhen Mindray Bio-medical Elect510(k) NO: K170876(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 23-AUG-17
Shenzhen  TW 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DD cubeX2 HS
Dental Direkt GmbH                510(k) NO: K170885(Traditional)
ATTN: Uwe  Greitens               PHONE NO : 49 052 25863190 
Industriezentrum 106-108          SE DECISION MADE: 01-AUG-17
Spenge  DE 32139                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovis S141 Lumbar Interbody Fusion System
Renovis Surgical Technologies     510(k) NO: K170888(Traditional)
ATTN: Anthony  DeBenedictis       PHONE NO : 909 5572360 
1901 W. Lugonia                   SE DECISION MADE: 08-AUG-17
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zirconia Dental Ceramics
CHENGDU BESMILE BIOTECHNOLOGY CO.,510(k) NO: K170894(Traditional)
ATTN: Moushan  Liu                PHONE NO : 86 28 88415850 
NO.1666, Chenglong Road Section TwSE DECISION MADE: 01-AUG-17
Chengdu  CN 610100                510(k) STATEMENT
                                                    

DEVICE: Medacta Anatomic Shoulder Prosthesis
Medacta International SA          510(k) NO: K170910(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 16-AUG-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEOCERA Advanced Barrier Cream
EXELTIS USA Dermatology, LLC      510(k) NO: K170911(Traditional)
ATTN: Babu  Lad                   PHONE NO : 973 3240200 
180 Park Avenue, Suite 101        SE DECISION MADE: 22-AUG-17
Florham Park NJ  07932            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The TiBow Expandable Spacer System
Life Spine Inc.                   510(k) NO: K170919(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 03-AUG-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CADence System
AUM Cardiovascular, Inc.          510(k) NO: K170928(Traditional)
ATTN: Marie  Johnson              PHONE NO : 612 7992511 
1405 Heritage Dr, Suite 100       SE DECISION MADE: 03-AUG-17
Northfield MN  55057              510(k) STATEMENT
                                                    

DEVICE: Supplemental Instrument Trays
NuVasive Specialized Orthopedics, 510(k) NO: K170939(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 5446478 
101 Enterprise                    SE DECISION MADE: 08-AUG-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
Tricol Biomedical Inc.            510(k) NO: K170958(Traditional)
ATTN: Maire Ni Beilliu            PHONE NO : 1 971 3275729 
720 SW Washington Street, Suite 20SE DECISION MADE: 29-AUG-17
Portland OR  97205                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROPHECY INVISION Pre-operative Navigation System
Wright Medical Technology, Inc.   510(k) NO: K170968(Traditional)
ATTN: Alayne  Melancon            PHONE NO : 1 901 2905986 
1023 Cherry Road                  SE DECISION MADE: 16-AUG-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Ankle Fibula Hook Plate System
Jeil Medical Corporation          510(k) NO: K170979(Traditional)
ATTN: Sejin  RYU                  PHONE NO : 82 2 8503500 
#702, Kolon Science Valley 2nd 55,SE DECISION MADE: 17-AUG-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
Smiths Medical ADS, Inc.          510(k) NO: K170982(Traditional)
ATTN: Breanna  Fautsch            PHONE NO : 763 3833258 
6000 Nathan Lane North            SE DECISION MADE: 24-AUG-17
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LG BEAUTY LED MASK
LG Electronics                    510(k) NO: K170984(Traditional)
ATTN: Jooyong  Kim                PHONE NO : 82 237 775497 
222 LG-ro Jinwi-myeon             SE DECISION MADE: 23-AUG-17
Pyeongtaek-si  KR 17709           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Captus Vascular Retrieval System
Avantec Vascular Corporation      510(k) NO: K170987(Traditional)
ATTN: Nicholas  deBeer            PHONE NO : 408 3295459 
605 W. California Avenue          SE DECISION MADE: 28-AUG-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Latitude EV Total Elbow Arthroplasty
Tornier Inc.                      510(k) NO: K171010(Traditional)
ATTN: Renee  Stoffel              PHONE NO : 952 6837471 
10801 Nesbitt Ave South           SE DECISION MADE: 31-AUG-17
Bloomington MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ShockPulse-SE Lithotripsy System
Cybersonics, Inc.                 510(k) NO: K171024(Traditional)
ATTN: Samradni  Patil             PHONE NO : 814 9201510 
Knowledge Park, 5340 Fryling Road,SE DECISION MADE: 21-AUG-17
Erie PA  16510                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
GE Healthcare Finland OY          510(k) NO: K171028(Traditional)
ATTN: Anna  Pehrsson              PHONE NO : 358 40 5695018 
Kuortaneenkatu 2                  SE DECISION MADE: 17-AUG-17
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hearing Healthcare Pro
dB Diagnostic Systems, Inc.       510(k) NO: K171038(Traditional)
ATTN: Steven  Levine              PHONE NO : 203 9840240 
17 Sachem Road                    SE DECISION MADE: 02-AUG-17
Weston CT  06883                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Assut Filbloc Permanent Sutures
Assut Europe S.p.A.               510(k) NO: K171039(Abbreviated)
ATTN: Gloria  Aggio               PHONE NO : 39 06 72677348 
Zona Industriale                  SE DECISION MADE: 29-AUG-17
Magliano dei Marsi  IT 67062      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SilverSeal
Alliqua BioMedical, Inc           510(k) NO: K171041(Traditional)
ATTN: Johanna  Reinert            PHONE NO : 267 3261806 
2150 Cabot Boulevard West Suite B SE DECISION MADE: 22-AUG-17
Langhorne PA  19047               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K171048(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 221 941594 
42, Teheran-ro 108-gil            SE DECISION MADE: 24-AUG-17
Seoul  KR 06176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BP5S Wireless Blood Pressure Monitor
Andon Health Co., Ltd.            510(k) NO: K171062(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 228 7611660 9060
No.3 Jin Ping Street Ya An Road, NSE DECISION MADE: 01-AUG-17
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K171070(Traditional)
ATTN: Emily  Woo                  PHONE NO : 82 2 21947120 
42, Teheran-ro 108-gil            SE DECISION MADE: 09-AUG-17
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StimSox(TM) System
StimMed, LLC                      510(k) NO: K171071(Traditional)
ATTN: Peter G. Demakos            PHONE NO : 888 784663 
388 Evans Street                  SE DECISION MADE: 09-AUG-17
Williamsville NY  14221           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Calix-C Cervical Interbody Spacer
X-Spine Systems, Inc.             510(k) NO: K171075(Traditional)
ATTN: Kriss  Andersson            PHONE NO : 937 8478400 2137
452 Alexandersville Rd            SE DECISION MADE: 01-AUG-17
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEXA100 (hexafocon A) Daily Wear Contact Lenses
CONTAMAC Ltd.                     510(k) NO: K171077(Traditional)
ATTN: Rob  McGregor               PHONE NO : 44 1799 542000 
Carlton House Shire Hill          SE DECISION MADE: 01-AUG-17
Saffron Walden  GB CB11 3AU       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-Switched Nd:YAG Laser System
IDS, Ltd.                         510(k) NO: K171079(Traditional)
ATTN: C. J. Park                  PHONE NO : 82 2 20251153 
#105, Byoksan Digital Valley 3 chaSE DECISION MADE: 01-AUG-17
Seoul  KR                         510(k) STATEMENT
                                                    

DEVICE: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
YTY INDUSTRY (MANJUNG) SDN BHD    510(k) NO: K171104(Traditional)
ATTN: Punitha  Samy               PHONE NO : 60 5 6908534 
Lot 1422-1424, Batu 10 Lekir      SE DECISION MADE: 25-AUG-17
Sitiawan  MY 32020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
3M Health Care                    510(k) NO: K171116(Traditional)
ATTN: Linda  Johnsen              PHONE NO : 651 4303467 
3M Center, 2510 Conway Ave., BuildSE DECISION MADE: 10-AUG-17
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
Cair L.G.L                        510(k) NO: K171118(Traditional)
ATTN: Delphine  Molinari          PHONE NO : 33 0 478437707 
1, Allee des Chevreuils - Parc terSE DECISION MADE: 15-AUG-17
Lissieu  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden Wireless Input Unit WEE-1200
Nihon Kohden Corporation          510(k) NO: K171124(Traditional)
ATTN: Tom  Bento                  PHONE NO : 949 6809048 
1-31-4 Nisahiochiai, Shinjuku-Ku  SE DECISION MADE: 25-AUG-17
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Matrixx System
Nexxt Spine LLC                   510(k) NO: K171140(Traditional)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd, Suite B        SE DECISION MADE: 22-AUG-17
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relievant Medsystems RF Generator
Relievant Medsystems              510(k) NO: K171143(Traditional)
ATTN: Alex  DiNello               PHONE NO : 650 3681000 
2688 Middlefield Road, Suite A    SE DECISION MADE: 18-AUG-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REVEAL Bulk
Bisco, Inc.                       510(k) NO: K171147(Traditional)
ATTN: Ryan  Hobson                PHONE NO : 847 5346143 
1100 West Irving Park Road        SE DECISION MADE: 04-AUG-17
Schaumburg IL  60193              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI Anseris Hip Stem
OMNIlife science                  510(k) NO: K171156(Traditional)
ATTN: Christina  Rovaldi          PHONE NO : 774 2261857 
480 Paramount Drive               SE DECISION MADE: 17-AUG-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
Prestige Ameritech                510(k) NO: K171162(Abbreviated)
ATTN: Rex  Reese                  PHONE NO : 817 4272700 20
7201 Iron Horse Blvd.             SE DECISION MADE: 15-AUG-17
North Richland Hills TX  76180    510(k) STATEMENT
                                                    

DEVICE: U-Lite EXP
Sonoscanner                       510(k) NO: K171164(Traditional)
ATTN: Bruno  Richard              PHONE NO : 33 954 971557 
6 rue Andre Voguet                SE DECISION MADE: 03-AUG-17
Ivry Sur Seine  FR 94200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Skyn Original Polyisoprene Lubricated Male Condom - Flavored
Ansell Healthcare Products LLC.   510(k) NO: K171172(Abbreviated)
ATTN: Robert  Mahler              PHONE NO : 732 3452174 
111 Wood Avenue South, Suite 210  SE DECISION MADE: 02-AUG-17
Iselin NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoPediatrics Titanium PediPlates® System
OrthoPediatrics, Corp.            510(k) NO: K171173(Traditional)
ATTN: Adam  Cargill               PHONE NO : 574 2686379 
2850 Frontier Drive               SE DECISION MADE: 24-AUG-17
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROCOTYL® PRIME E-CLASS™ XLPE Liner
MicroPort Orthopedics, Inc.       510(k) NO: K171181(Traditional)
ATTN: Sarah Evonne Stroupe        PHONE NO : 901 2905165 
5677 Airline Road                 SE DECISION MADE: 28-AUG-17
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniTom
NeuroLogica Corporation,          510(k) NO: K171183(Traditional)
ATTN: Ninad  Gujar                PHONE NO : 978 5648503 
a Subsidiary of Samsung ElectronicSE DECISION MADE: 18-AUG-17
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hexagen Derm
Global Health Solutions, LLC      510(k) NO: K171191(Traditional)
ATTN: Bradley  Burnam             PHONE NO : 706 8441025 
1360 Redmond Circle               SE DECISION MADE: 25-AUG-17
Rome GA  30165                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Grandio blocs
VOCO GmbH                         510(k) NO: K171200(Traditional)
ATTN: M. Th. Plaumann             PHONE NO : 49 4721 71910 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 10-AUG-17
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: Arctic Sperm Cryopreservation Medium
Irvine Scientific Sales Co., Inc. 510(k) NO: K171224(Traditional)
ATTN: Jayme  Yamaguchi-Owens      PHONE NO : 800 4375706 254
2511 Daimler Street               SE DECISION MADE: 31-AUG-17
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sorbact Wound Dressing-Ribbon Gauze
ABIGO Medical AB                  510(k) NO: K171225(Traditional)
ATTN: Annica  Corbe               PHONE NO : 46 31 7484950 
Ekonomivagen 5                    SE DECISION MADE: 21-AUG-17
Askim  SE SE-436 33               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StarWalker
Fotona d.o.o.                     510(k) NO: K171227(Traditional)
ATTN: Stojan  Trost               PHONE NO : 386 1 5009299 
Stegne 7                          SE DECISION MADE: 18-AUG-17
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Physiotrace
NimbleHeart, Inc.                 510(k) NO: K171244(Traditional)
ATTN: Sonal  Tambe                PHONE NO : 408 4757630 
1300 White Oaks Rd., Suite #201   SE DECISION MADE: 23-AUG-17
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entrada™ hip stem
Ortho Development Corporation     510(k) NO: K171249(Traditional)
ATTN: Drew  Weaver                PHONE NO : 801 5539991 
12187 South Business Park Drive   SE DECISION MADE: 24-AUG-17
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ScannerSide DoseCheck
Right Dose Inc.                   510(k) NO: K171261(Traditional)
ATTN: William  Moore              PHONE NO : 631 4036731 
49 Amherst Road                   SE DECISION MADE: 18-AUG-17
Port Washington NY  11050         510(k) STATEMENT
                                                    

DEVICE: Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
TG Medical SDN. BHD.              510(k) NO: K171276(Traditional)
ATTN: Fatima Wati BT Mohamad      PHONE NO : 603 339 27880 
Lot 5091, Jalan Teratai Batu 5, OfSE DECISION MADE: 21-AUG-17
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: Fixone Biocomposite Anchor
AJU Pharm Co.,Ltd.                510(k) NO: K171299(Traditional)
ATTN: Kim Jung Gil                PHONE NO : 82 317 654420 
A-207, 697, Pangyo-ro             SE DECISION MADE: 24-AUG-17
Seongnam-si  KR 13511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced RBC Application
Cella Vision AB                   510(k) NO: K171315(Traditional)
ATTN: Cella  Vision AB            PHONE NO : 46 462 864400 
Ideon Science Park                SE DECISION MADE: 01-AUG-17
Lund  SE SE-223 70                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Navigation Instruments
K2M                               510(k) NO: K171321(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 30-AUG-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eCareManager 4.1
Visicu, Inc.                      510(k) NO: K171322(Traditional)
ATTN: Daniel R. Plonski           PHONE NO : 410 2465357 
217 East Redwood St. Suite 1900   SE DECISION MADE: 03-AUG-17
Baltimore MD  21202               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Titanium Interbody Fusion System
Altus Partners, LLC               510(k) NO: K171329(Special)
ATTN: Claudia  Hill               PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 29-AUG-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NxStage System One
NxStage Medical, Inc.             510(k) NO: K171331(Traditional)
ATTN: Paul  Kravitz               PHONE NO : 978 6874711 
350 Merrimack Street              SE DECISION MADE: 24-AUG-17
Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artemis Neuro Evacuation Device
Penumbra, Inc.                    510(k) NO: K171332(Traditional)
ATTN: Mary  Rose                  PHONE NO : 510 7483346 
One Penumbra Place                SE DECISION MADE: 14-AUG-17
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LENSAR Laser System – fs 3D (LLS-fs 3D)
LENSAR, Inc.                      510(k) NO: K171337(Traditional)
ATTN: Keith  Peck                 PHONE NO : 888 5756412 
2800 Discovery Drive, Suite 100   SE DECISION MADE: 10-AUG-17
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio 100 Series Systems with Confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K171345(Traditional)
ATTN: Veronique  Dentan           PHONE NO : 33 17 0080994 
9 Rue d'Enghien                   SE DECISION MADE: 04-AUG-17
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire Sets
ICU Medical                       510(k) NO: K171346(Traditional)
ATTN: Andrea  Doyle               PHONE NO : 224 2124235 
600 N. Field Drive                SE DECISION MADE: 25-AUG-17
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarity Reveal
Ceevra, Inc.                      510(k) NO: K171356(Traditional)
ATTN: Russ  Yoshinaka             PHONE NO : 415 9269434 
3960 Franke Ln.                   SE DECISION MADE: 03-AUG-17
Lafayette CA  94549               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Syringe
Merit Medical Systems, Inc.       510(k) NO: K171362(Abbreviated)
ATTN: Cory  Marsh                 PHONE NO : 801 3163690 
1600 W Merit Parkway              SE DECISION MADE: 07-AUG-17
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
Stimwave Technologies Inc.,DBA Sti510(k) NO: K171366(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 786 4757228 
901 East Las Olas Boulevard , SuitSE DECISION MADE: 04-AUG-17
Fort Lauderdale FL  33301         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. MINI Posterior Cervical Screws System
Medacta International SA          510(k) NO: K171369(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 916 966060 
Strada Regina                     SE DECISION MADE: 01-AUG-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dpl SpectraLite
LED Technologies, Inc.            510(k) NO: K171386(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 4076884 
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 07-AUG-17
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOLUTION Revision CCK System
MicroPort Orthopedics Inc.        510(k) NO: K171389(Traditional)
ATTN: Matt  Paul                  PHONE NO : 901 8674350 
5677 Airline Road                 SE DECISION MADE: 08-AUG-17
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dpl II Panel
LED Technologies, Inc.            510(k) NO: K171390(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 4076884 
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 03-AUG-17
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optum TeleHealth Application
United Health Group Inc.          510(k) NO: K171406(Special)
ATTN: Donald J. Matthews          PHONE NO : 914 9334715 
1100 King Street, Buliding 6, SuitSE DECISION MADE: 18-AUG-17
Rye Brook NY  10573               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExsoMed ArcPhix and ExsoMed ArrowPhix
ExsoMed Holding Company, LLC      510(k) NO: K171407(Traditional)
ATTN: Richard L. Kovach           PHONE NO : 602 4663186 
7227 N. 16th Street, Suite 245    SE DECISION MADE: 18-AUG-17
Phoenix AZ  85020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm
BioStable Science & Engineering, I510(k) NO: K171431(Traditional)
ATTN: Julie  Thomas               PHONE NO : 512 9709112 
2621 Ridgepoint Dr., Suite 100    SE DECISION MADE: 10-AUG-17
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silk'n Infinity
Home Skinovations Ltd.            510(k) NO: K171433(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 11-AUG-17
Yoqneam Illit  IL                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YUKON OCT Spinal System
K2M, Inc.                         510(k) NO: K171444(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 08-AUG-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ahmed Glaucoma Valve Model FP8
New World Medical, Inc.           510(k) NO: K171451(Traditional)
ATTN: Cristina  Avalos            PHONE NO : 909 2437722 
10763 Edison Court                SE DECISION MADE: 08-AUG-17
Rancho Cucamonga CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAMBA and MAMBA FLEX Microcatheters
Boston Scientific Corporation     510(k) NO: K171452(Traditional)
ATTN: Sherry  Kollmann            PHONE NO : 763 4941111 
Three Scimed Place                SE DECISION MADE: 21-AUG-17
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Choice Spine                      510(k) NO: K171456(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 03-AUG-17
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceribell Instant EEG Headband
Ceribell, Inc.                    510(k) NO: K171459(Traditional)
ATTN: Josef  Parvizi              PHONE NO : 650 5217003 
2483 Old Middlefield Way, Suite 12SE DECISION MADE: 21-AUG-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Self-Punching ICONIX
Stryker                           510(k) NO: K171465(Traditional)
ATTN: Katie  Farraro              PHONE NO : 408 7542285 
5900 Optical Ct                   SE DECISION MADE: 24-AUG-17
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeRoyal Laprador Specimen Retrieval System
DeRoyal Industries, Inc.          510(k) NO: K171475(Traditional)
ATTN: Sarah  Bennett              PHONE NO : 865 3626112 
200 DeBusk Lane                   SE DECISION MADE: 17-AUG-17
Powell TN  37849                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sirius MRI Marker NS
C4 Imaging, LLC                   510(k) NO: K171487(Traditional)
ATTN: Andrew  Bright              PHONE NO : 609 9335895 
196 West Ashland Street           SE DECISION MADE: 25-AUG-17
Doylestown PA  18901              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MegaVac Mechanical Thrombectomy System
Capture Vascular, Inc.            510(k) NO: K171493(Special)
ATTN: Aaron  Call                 PHONE NO : 480 5598819 
620 Mountain Village Blvd. Suite 2SE DECISION MADE: 10-AUG-17
Mountain Village CO  81435        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY Assert VH2O2 Self-Contained Biological Indicator
STERIS Corporation                510(k) NO: K171504(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 22-AUG-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Easyscreen
Maico Diagnostics GmbH            510(k) NO: K171506(Traditional)
ATTN: Amy  Yanta                  PHONE NO : 952 9476097 
Sickingenstr. 70-71               SE DECISION MADE: 29-AUG-17
Berlin  DE 10553                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RIDA GENE Norovirus GI/GII
R-Biopharm AG                     510(k) NO: K171511(Traditional)
ATTN: Andreas  Simons             PHONE NO : 49 0 6151810296 
An der neuen Bergstrabe 17        SE DECISION MADE: 21-AUG-17
Darmstadt  DE 64297               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monopolar Single Use Laparoscopic Instrument
Getsch+Hiller Medizintechnik GmbH 510(k) NO: K171523(Traditional)
ATTN: Werner  Hiller              PHONE NO : 49 7461 130510 
Sattlerstr.20                     SE DECISION MADE: 22-AUG-17
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenius™, lliad™ and Kora™ Spinal Fixation Systems
Medyssey USA, Inc.                510(k) NO: K171526(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 1 847 4270200 
1550 East Higgins Road, Suite 123 SE DECISION MADE: 21-AUG-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Refobacin Bone Cement R
Biomet Inc.                       510(k) NO: K171540(Traditional)
ATTN: Heidi  Busz                 PHONE NO : 574 3724249 
56 East Bell Drive                SE DECISION MADE: 30-AUG-17
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTIS Optical Coherence Tomography System
Perimeter Medical Imaging, Inc.   510(k) NO: K171560(Traditional)
ATTN: Elizabeth  Munro            PHONE NO : 1 877 2784614 
47 Colborne Street Suite 202      SE DECISION MADE: 25-AUG-17
Toronto  CA M5E 1P8               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
Dextera Surgical Inc.             510(k) NO: K171561(Traditional)
ATTN: Greg  Watson                PHONE NO : 949 4129808 
900 Saginaw Drive                 SE DECISION MADE: 28-AUG-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagnetOs Putty
Kuros Biosciences B.V.            510(k) NO: K171563(Traditional)
ATTN: Yvonne P. Bovell            PHONE NO : 31 30 2297280 
Professor Bronkhorstlaan 10, buildSE DECISION MADE: 24-AUG-17
Bilthoven  NL 3723MB              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC Elite
GE OEC Medical Systems, Inc.      510(k) NO: K171565(Traditional)
ATTN: Rachel  Schandel            PHONE NO : 801 5364790 
384 Wright Brothers Drive         SE DECISION MADE: 10-AUG-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRIX-A Lumbar Integrated Fusion System
X-Spine Systems, Inc.             510(k) NO: K171567(Traditional)
ATTN: Kriss  Andersson            PHONE NO : 937 8478400 2137
452 Alexanderville Rd.            SE DECISION MADE: 28-AUG-17
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Additional VIPER PRIME™ screws with fenestrations
Medos International, SARL         510(k) NO: K171570(Special)
ATTN: Karen  Sylvia               PHONE NO : 508 9773804 
Chemin-Blanc 38                   SE DECISION MADE: 31-AUG-17
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
Steris Corporation                510(k) NO: K171587(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5976 Heisley Rd                   SE DECISION MADE: 22-AUG-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
ConMed Corporation                510(k) NO: K171592(Traditional)
ATTN: Diana L. Nader-Martone      PHONE NO : 727 3995425 
525 French Road                   SE DECISION MADE: 29-AUG-17
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Medacta International SA          510(k) NO: K171595(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 02-AUG-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
Wilson-Cook Medical Inc.          510(k) NO: K171596(Traditional)
ATTN: Tiffanny A. Thomas          PHONE NO : 336 7440157 6680
4900 Bethania Station Road        SE DECISION MADE: 04-AUG-17
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OKI Surgical Planning Software
Ortho Kinematics, Inc.            510(k) NO: K171617(Traditional)
ATTN: Adam  Deitz                 PHONE NO : 512 3345490 
110 Wild Basin Road, Suite 250    SE DECISION MADE: 22-AUG-17
Austin TX  78704                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 14Fr Colon Decompression Set, Macon Colon Decompression Set
Cook Ireland Ltd                  510(k) NO: K171619(Traditional)
ATTN: Laura  Graham               PHONE NO : 011 353 61334440 
O'Halloran Road, National TechnoloSE DECISION MADE: 01-AUG-17
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA Medical, Inc.                 510(k) NO: K171626(Traditional)
ATTN: Sherrie  Coval-Goldsmith    PHONE NO : 781 5384720 
91 Hartwell Avenue                SE DECISION MADE: 30-AUG-17
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trojan Supra Lubricated Polyurethane Male Condom
Church & Dwight Co., Inc.         510(k) NO: K171639(Traditional)
ATTN: Lisa  Burns                 PHONE NO : 609 8061997 
500 Charles Ewing Blvd.           SE DECISION MADE: 01-AUG-17
Ewing NJ  08628                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica IM Ferritin Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K171642(Traditional)
ATTN: Kira  Gordon                PHONE NO : 914 5242996 
511 Benedict Ave.                 SE DECISION MADE: 31-AUG-17
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXCELSIUS GPS
Globus Medical Inc.               510(k) NO: K171651(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 16-AUG-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ShurFit 2C Lumbar Interbody Fusion System
Precision Spine, Inc.             510(k) NO: K171657(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 601 4204244 128
2050 Executive Drive              SE DECISION MADE: 11-AUG-17
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Duo Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K171660(Special)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 18-AUG-17
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epix Electrosurgical Probe with Smoke Evacuation
Applied Medical Resources Corporat510(k) NO: K171684(Traditional)
ATTN: Aditi  Iyengar              PHONE NO : 949 7138007 
22872 Avenida Empresa             SE DECISION MADE: 07-AUG-17
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPRI Corpectomy Cage System
K2M                               510(k) NO: K171704(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 31-AUG-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
Gowoonsesang Cosmetics Co., Ltd   510(k) NO: K171707(Traditional)
ATTN: Kyeong Tai Ko               PHONE NO : 82 317 249009 
(Seohyeon-dong, 4, 5F Cocoplaza) 2SE DECISION MADE: 08-AUG-17
Seongnam-si  KR 13591             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
William Cook Europe ApS           510(k) NO: K171712(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 45 568 68756 
Sandet 6                          SE DECISION MADE: 07-AUG-17
Bjaeverskov  DK 4632              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKR 3000
Konica Minolta, Inc.              510(k) NO: K171716(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 25-AUG-17
Hino-shi  JP 191-8511             510(k) STATEMENT
                                                    

DEVICE: AUTOCON III 400
KARL STORZ Endoscopy-America, Inc.510(k) NO: K171717(Third Party - Traditional)
ATTN: AnnaLisa  Smullin           PHONE NO : 424 2188376 
2151 E. Grand Avenue              SE DECISION MADE: 02-AUG-17
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
C.R. Bard, Inc.                   510(k) NO: K171735(Special)
ATTN: Jeremy  Tidwell             PHONE NO : 801 5225665 
605 North 5600 West               SE DECISION MADE: 08-AUG-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Supria True64
Hitachi Healthcare Americas Corpor510(k) NO: K171738(Special)
ATTN: Doug  Thistlethwaite        PHONE NO : 1 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 18-AUG-17
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laport
Sejong Medical Co., Ltd.          510(k) NO: K171741(Traditional)
ATTN: Yoojung  Choi               PHONE NO : 
11, Sinchon 2-ro                  SE DECISION MADE: 29-AUG-17
Paju-si  KR 10880                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Combined Set Screws
Medacta International SA          510(k) NO: K171758(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 01-AUG-17
Castel San Pietro  CH ch-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGEC® System
NuVasive Specialized Orthopedics, 510(k) NO: K171791(Traditional)
ATTN: Manthan J. Damani           PHONE NO : 858 4582272 
101 Enterprise Suite 100          SE DECISION MADE: 31-AUG-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sequential Circulator SC-2004FC-OC
Bio Compression Systems, Inc.     510(k) NO: K171793(Special)
ATTN: Barbara J. Whitman          PHONE NO : 800 8880908 
120 W Commercial Ave              SE DECISION MADE: 17-AUG-17
Moonachie NJ  07074               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epic Biliary Endoscopic Stent System
Boston Scientific Corporation     510(k) NO: K171809(Traditional)
ATTN: Thomas  Hirte               PHONE NO : 508 6834430 
100 Boston Scientific Way         SE DECISION MADE: 09-AUG-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMBA Hourglass Peripheral Embolization Device
EMBA Medical Limited              510(k) NO: K171845(Traditional)
ATTN: Veronica  Reott             PHONE NO : 954 8741016 
3451 Commerce Pkwy                SE DECISION MADE: 18-AUG-17
Miramar FL  33025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liver Access and Biopsy Sets
Cook Incorporated                 510(k) NO: K171853(Traditional)
ATTN: David  Lehr                 PHONE NO : 812 3392235 2309
750 Daniels Way                   SE DECISION MADE: 24-AUG-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
Farus, LLC                        510(k) NO: K171865(Traditional)
ATTN: Rahul  Singh                PHONE NO : 310 3464781 
1240 Keystone Way                 SE DECISION MADE: 24-AUG-17
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL
Thermo Fisher Scientific          510(k) NO: K171870(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909322 4117
1 Thermo Fisher Way               SE DECISION MADE: 01-AUG-17
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: JAZZ Passer Band
Implanet, S.A.                    510(k) NO: K171881(Traditional)
ATTN: Fabienne Larquey Cadiere    PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 08-AUG-17
Martillac  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Grivamax Hair Growth System
Leana Orders, Inc.                510(k) NO: K171895(Traditional)
ATTN: Leonid  Krits               PHONE NO : 718 4151901 
431 Travis Avenue                 SE DECISION MADE: 22-AUG-17
Staten Island NY  10314-6150      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Feminine Personal Trainer (FPT)
Ralston Group                     510(k) NO: K171896(Traditional)
ATTN: Russell  Ralston            PHONE NO : 334 8752298 
656 Lake Lanier Rd.               SE DECISION MADE: 29-AUG-17
Selma AL  36701                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Approach CTO Microwire Guide
Cook Incorporated                 510(k) NO: K171897(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 21-AUG-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
Better Care Plastic Technology Co.510(k) NO: K171898(Traditional)
ATTN: Zhu  Chunyan                PHONE NO : 86 311 83601854 
Fuqian Xi Road, West district of SSE DECISION MADE: 18-AUG-17
Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarix AX4 Diagnostic Ultrasound System
Edan Instruments, Inc             510(k) NO: K171900(Traditional)
ATTN: Crystal  Cai                PHONE NO : 86 755 26858736 
#15 Jinhui Road,Jinsha Community KSE DECISION MADE: 18-AUG-17
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
Liofilchem s. r. l.               510(k) NO: K171906(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 01-AUG-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc.               510(k) NO: K171921(Traditional)
ATTN: Hans  Kjolhede              PHONE NO : 508 6587944 
26 Forest Street                  SE DECISION MADE: 24-AUG-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
Visionary Optics LLC              510(k) NO: K171950(Traditional)
ATTN: Donald R. Sanders           PHONE NO : 630 5309700 
1325 Progress Drive               SE DECISION MADE: 16-AUG-17
Front Royal VA  22630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Delafloxacin 5 µg (DLX5)
Hardy Diagnostics                 510(k) NO: K171975(Traditional)
ATTN: Rianna  Malherbe            PHONE NO : 805 3462766 
1430 West McCoy Lane              SE DECISION MADE: 01-AUG-17
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
Creo Medical Ltd                  510(k) NO: K171983(Traditional)
ATTN: Keith  Penny                PHONE NO : 44 012 91606005 
Riverside Court, Beaufort Park    SE DECISION MADE: 17-AUG-17
Chepstow  GB NP16 5uh             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astroglide O Oil Personal Lubricant & Massage Oil
BioFilm Inc.                      510(k) NO: K171985(Traditional)
ATTN: Richard  Hines              PHONE NO : 1 760 7279030 
3225 Executive Ridge              SE DECISION MADE: 30-AUG-17
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmon Needle Knife Papillotome
Wilson-Cook Medical, Inc. / Cook E510(k) NO: K171993(Traditional)
ATTN: Doris A. Hawks              PHONE NO : 336 7440157 396293
4900 Bethania Station Road        SE DECISION MADE: 17-AUG-17
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalys Precision Laser System
AMO Manufacturing USA, LLC        510(k) NO: K172002(Traditional)
ATTN: Anita  Xavier               PHONE NO : 408 2734025 
510 Cottonwood Drive              SE DECISION MADE: 25-AUG-17
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truSculpt
Cutera, Inc.                      510(k) NO: K172004(Special)
ATTN: Bradley  Renton             PHONE NO : 415 6575568 
3240 Bayshore Blvd.               SE DECISION MADE: 02-AUG-17
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaPASS
Medicrea International S.A.       510(k) NO: K172021(Traditional)
ATTN: David  Ryan                 PHONE NO : 00 33472 018787 
5389 route de Strasbourg - Vancia SE DECISION MADE: 30-AUG-17
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pirouette High Pressure (HP)
ArraVasc Ltd                      510(k) NO: K172033(Traditional)
ATTN: Carmel  Doherty             PHONE NO : 353 91 758939 55
2 Ballybrit Business Park         SE DECISION MADE: 31-AUG-17
Galway  IE h91dt7c                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medrobotics Flex Robotic System
Medrobotics Corporation           510(k) NO: K172036(Special)
ATTN: John D. Bonasera            PHONE NO : 508 6926460 
475 Paramount Drive               SE DECISION MADE: 03-AUG-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATHTONG II PICC Catheter
L&Z US, Inc.                      510(k) NO: K172039(Special)
ATTN: Jenella  Coutts             PHONE NO : 718 6010889 1
6 Horizon Road                    SE DECISION MADE: 03-AUG-17
Fort Lee NJ  07024                510(k) STATEMENT
                                                    

DEVICE: CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
Cry IQ AB                         510(k) NO: K172049(Traditional)
ATTN: Stefan  Skafte              PHONE NO : 46 31 400500 
Apelrodsvagen 1                   SE DECISION MADE: 30-AUG-17
Onsala  SE 43932                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DUS-7000 Digital Color Doppler Ultrasound System
Advanced Instrumentations, Inc    510(k) NO: K172055(Abbreviated)
ATTN: Jorge  Millan               PHONE NO : 305___ 4776331 
6800 NW 77th Ct                   SE DECISION MADE: 31-AUG-17
Miami FL  33166                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE UNYTE System
NuVasive Specialized Orthopedics, 510(k) NO: K172061(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 5446478 
101 Enterprise, Suite 100         SE DECISION MADE: 24-AUG-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
Alcon Laboratories, Inc.          510(k) NO: K172066(Special)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 09-AUG-17
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hi-Torque Command 18 Guide Wire
Abbott Vascular                   510(k) NO: K172073(Special)
ATTN: Kathyrene  Logrono          PHONE NO : 408 8450597 
3200 Lakeside Drive               SE DECISION MADE: 25-AUG-17
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maestro Microcatheter
Merit Medical Systems, Inc.       510(k) NO: K172081(Special)
ATTN: Niloufar  Samimi            PHONE NO : 801 2084583 
1600 West Merit Parkway           SE DECISION MADE: 04-AUG-17
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta III Lithotripter
Dornier MedTech America, Inc.     510(k) NO: K172084(Special)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts Blvd Suite 100       SE DECISION MADE: 08-AUG-17
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
Centers for Disease Control and Pr510(k) NO: K172091(Traditional)
ATTN: Yon  Yu                     PHONE NO : 404 6393046 
1600 Clifton Rd., MS E-51         SE DECISION MADE: 09-AUG-17
Atlanta GA  30329-4027            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fraxis
Ilooda Co. LTD                    510(k) NO: K172096(Special)
ATTN: Kathy  Maynor               PHONE NO : 720 9625412 
120, Jangan-Ro 458 Beon-Gil JanganSE DECISION MADE: 09-AUG-17
Suwon-Si Gyeonggido  KR 16200     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Video Endoscope System
Zhuhai Pusen Medical Technology Co510(k) NO: K172098(Third Party - Traditional)
ATTN: WANG  CHANGSHEN             PHONE NO : 086 75 66880096 
5/F, Building 1, No 33, Keji San RSE DECISION MADE: 31-AUG-17
Zhuhai  CN 519085                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Ozark(tm) Cervical Plate System
K2M Inc.                          510(k) NO: K172104(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 703 7773155 
600 Hope Pkwy. SE                 SE DECISION MADE: 23-AUG-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SHOFU MZ Primer Plus
Shofu Dental Corporation          510(k) NO: K172106(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 Stone Drive                  SE DECISION MADE: 31-AUG-17
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System
Spineology Inc.                   510(k) NO: K172107(Traditional)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street North             SE DECISION MADE: 21-AUG-17
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Natural Nail System
Zimmer Inc.                       510(k) NO: K172114(Special)
ATTN: Dhaval  Saraiya             PHONE NO : 305 2696386 
345 East Main Street              SE DECISION MADE: 10-AUG-17
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOZO
ImpediMed Limited                 510(k) NO: K172122(Special)
ATTN: Catherine  Kingsford        PHONE NO : 61 738 603703 
Unit 1 50 Parker Court            SE DECISION MADE: 11-AUG-17
Pinkenba  AU 4008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K172129(Third Party - Traditional)
ATTN: JiYeon  Cho                 PHONE NO : 82 2 21945431 
42, Techeran-ro 108-gil, Gangnam-gSE DECISION MADE: 08-AUG-17
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 2 Hole Lateral Plating System
Life Spine Inc.                   510(k) NO: K172131(Traditional)
ATTN: Randy  Lewis                PHONE NO : 1 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 28-AUG-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Streamline OCT Occipito-Cervico-Thoracic System
Pioneer Surgical Technology, Inc. 510(k) NO: K172139(Traditional)
ATTN: Sarah  Pleaugh              PHONE NO : 906 2269909 
375 River Park Circle             SE DECISION MADE: 18-AUG-17
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
PolyNovo Biomaterials Pty Ltd     510(k) NO: K172140(Special)
ATTN: Sue  Cho                    PHONE NO : 61 3 86814050 
Unit 2, 320 Lorimer Street        SE DECISION MADE: 11-AUG-17
Port Melbourne  AU 3207           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
Siemens Healthcare                510(k) NO: K172162(Third Party - Traditional)
ATTN: Jessica  Stenberg           PHONE NO : 425 3929180 
22010 SE 51st St                  SE DECISION MADE: 16-AUG-17
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Eclipse Treatment Planning System
Varian Medical Systems, Inc.      510(k) NO: K172163(Special)
ATTN: Peter J. Coronado           PHONE NO : 1 650 4246320 
911 Hansen Way                    SE DECISION MADE: 15-AUG-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-Fix Suture Anchor
ArthroCare Corporation            510(k) NO: K172165(Special)
ATTN: Laura  Kasperowicz          PHONE NO : 949 5852406 
15285 Alton Parkway Suite 200     SE DECISION MADE: 17-AUG-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapSure® PS System
Spine Wave, Inc.                  510(k) NO: K172175(Special)
ATTN: Amy  Noccioli               PHONE NO : 203 9449494 
3 Enterprise Drive, Suite 210     SE DECISION MADE: 16-AUG-17
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTIEN Measurement System
St. Jude Medical (now part of the 510(k) NO: K172182(Special)
ATTN: Julie  Dalquist             PHONE NO : 651 7563501 
One St.Jude Medical Device        SE DECISION MADE: 18-AUG-17
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Connector System
Orthofix Inc.                     510(k) NO: K172194(Traditional)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 18-AUG-17
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Intima II PLUS Closed IV Catheter System
Becton, Dickinson and Company     510(k) NO: K172204(Third Party - Traditional)
ATTN: Henry  Boland               PHONE NO : 1 801 5652300 
9450 South State Street           SE DECISION MADE: 17-AUG-17
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Standard Supreme Sterilization Wrapper
Standard Textile Co., Inc.        510(k) NO: K172207(Traditional)
ATTN: Bradley J. Bushman          PHONE NO : 513 7619255 2455
One Knollcrest Drive              SE DECISION MADE: 25-AUG-17
Cincinnati OH  45237              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
G-21 s.r.l.                       510(k) NO: K172214(Special)
ATTN: Maurizio  Foroni            PHONE NO : 39 0535 30312 
Via S. Pertini, 8                 SE DECISION MADE: 23-AUG-17
San Possidonio  IT 41039          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACIST RXi Mini System
ACIST Medical Systems, Inc.       510(k) NO: K172216(Special)
ATTN: Amber  Luker                PHONE NO : 952 9959300 
7905 Fuller Road                  SE DECISION MADE: 18-AUG-17
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Perfusion System 1
Terumo Cardiovascular Systems Corp510(k) NO: K172220(Special)
ATTN: Bryan K. Hann               PHONE NO : 734 7415816 
6200 Jackson Road                 SE DECISION MADE: 17-AUG-17
Ann Arbor MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Injection Needle
Carbon Medical Technologies, Inc. 510(k) NO: K172227(Special)
ATTN: Andrew J. Adams             PHONE NO : 651 6538512 
1290 Hammond Road                 SE DECISION MADE: 23-AUG-17
Saint Paul MN  55110-5867         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Plating System
Smith & Nephew, Inc.              510(k) NO: K172262(Special)
ATTN: Samantha  Staubach          PHONE NO : 901 3996132 
1450 Brooks Road                  SE DECISION MADE: 23-AUG-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
Thermo Fisher Scientific          510(k) NO: K172274(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322411
1 Thermo Fisher Way               SE DECISION MADE: 30-AUG-17
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: VMA™ System version 3.0
Ortho Kinematics, Inc.            510(k) NO: K172327(Traditional)
ATTN: Adam  Deitz                 PHONE NO : 512 3345490 
110 Wild Basin Road, Suite 250    SE DECISION MADE: 25-AUG-17
Austin TX  78704                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroLift System (UL500)
NeoTract, Inc.                    510(k) NO: K172359(Special)
ATTN: Louis-Pierre  Marcoux       PHONE NO : 925 2018861 
4473 Willow Road Suite 100        SE DECISION MADE: 18-AUG-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzDent-i / E2 / Prora View
Ewoo Soft Co., Ltd.               510(k) NO: K172364(Traditional)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg. 13, SSE DECISION MADE: 22-AUG-17
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Integrated Bipolar Cord and Tubing Sets
Stryker Instruments               510(k) NO: K172367(Special)
ATTN: Susanne  Galin              PHONE NO : 269 38984132 
4100 E. Milham Avenue             SE DECISION MADE: 22-AUG-17
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON NX2 Diagnostic Ultrasound System,  ACUSON NX2 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K172374(Third Party - Traditional)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 East Middlefield Road         SE DECISION MADE: 15-AUG-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
Volcano AtheroMed Inc             510(k) NO: K172386(Special)
ATTN: Jean  Chnag                 PHONE NO : 916 2812937 
1530 O'Brien Drive Suite A        SE DECISION MADE: 24-AUG-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Blue Digi LED Curing Light
Promident LLC                     510(k) NO: K172426(Third Party - Traditional)
ATTN: Gary  Kris                  PHONE NO : 845 5890210 
618 Corporate Way Unit 1          SE DECISION MADE: 16-AUG-17
Valley Cottage NY  10989          510(k) STATEMENT
                                  THIRD PARTY REVIEW


              TOTAL 510(k)s THIS PERIOD   280                                     
              TOTAL WITH SUMMARIES        258                                     
              TOTAL WITH STATEMENTS        22