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  1. Device Approvals, Denials and Clearances

October 2017 510(k) Clearances

October 2017 510(k) Clearances

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


DEVICE: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
SD BIOSENSOR                      510(k) NO: K160282(Traditional)
ATTN: Sunok   Go                  PHONE NO : 82 31 3000416 
C-4th & 5th, 16, Deogyeong-daero, SE DECISION MADE: 17-OCT-17
Suwon-si  KR 443-813              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
PTW-FREIBURG PHYSIKALISCH-TECHNISC510(k) NO: K160405(Traditional)
ATTN: Sandor-Csaba  Ats           PHONE NO : 49 761 49055896 
LOERRACHER STR.7                  SE DECISION MADE: 20-OCT-17
FREIBURG  DE 79115                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiScanner 5000 Glucose Monitoring System
OPTISCAN BIOMEDICAL CORP.         510(k) NO: K162042(Traditional)
ATTN: DON  WEBBER                 PHONE NO : 510 9626223 
24590 CLAWITER ROAD               SE DECISION MADE: 16-OCT-17
HAYWARD CA  94545                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRI-FILL PERISTALTIC SET
LABORATORIOS GRIFOLS, S.A.        510(k) NO: K162216(Abbreviated)
ATTN: MARTA DANIELA SERRA DE FORTUPHONE NO : 34 93 5710100 
C/CAN GUASCH, 2                   SE DECISION MADE: 19-OCT-17
PARETS DEL VALLES,  ES 08150      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stomach Tube
WELL LEAD MEDICAL CO., LTD        510(k) NO: K162340(Traditional)
ATTN: HUANG KAI GEN               PHONE NO : 86 208 4758878 
C-4# JINHU INDUSTRIAL ESTATE HUALOSE DECISION MADE: 11-OCT-17
GUANGZHOU  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
PMS TIBBI CIHAZLAR TEKNOLOJISI SAN510(k) NO: K162362(Traditional)
ATTN: DERYA  DIKICI               PHONE NO : 90 324 2387042 
KARADUVAR MAH.SERBEST BOLGE, 11.CASE DECISION MADE: 13-OCT-17
MERSIN  TR 33020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Photon Micro-current Device, Model: EP-300
LI-TEK ELECTRONIC TECHNOLOGY CORPO510(k) NO: K162652(Traditional)
ATTN: Barry  Yuan                 PHONE NO : 86 0769 83117755 
NO.8-13, THE INDUSTRIAL PARK OF JISE DECISION MADE: 25-OCT-17
DONGGUAN  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GingiDent Gingival Retraction Paste
PAC-DENT INTERNATIONAL, INC.      510(k) NO: K162662(Traditional)
ATTN: JIAQING  WU                 PHONE NO : 909 8390888 
670 ENDEAVOR CIRCLE               SE DECISION MADE: 20-OCT-17
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puritan Bennett 980 Ventilator System
Covidien                          510(k) NO: K162738(Traditional)
ATTN: Kelsey  Lee                 PHONE NO : 303 3052760 
6135 Gunbarrel Ave                SE DECISION MADE: 27-OCT-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advance Medical Designs, Inc. Sterile Ultrasound Gel
ADVANCE MEDICAL DESIGNS, INC.     510(k) NO: K163050(Traditional)
ATTN: DAVID  MACKIE               PHONE NO : 770 4223125 
1241 ATLANTA INDUSTRIAL DR.       SE DECISION MADE: 25-OCT-17
MARIETTA GA  30066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yooeehouse Breast Pump
Nantong Poly Technology Co., Ltd. 510(k) NO: K163183(Traditional)
ATTN: Rongmin  Lin                PHONE NO : 0086 0513 81528229 
No.332, Xinxing Road, Development SE DECISION MADE: 02-OCT-17
Nantong  CN 226010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperNO2VA Device
Revolutionary Medical Devices, Inc510(k) NO: K163277(Traditional)
ATTN: David M. Kane               PHONE NO : 520 8440729 
4090 E. Bujia Primera             SE DECISION MADE: 13-OCT-17
Tucson AZ  85718                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shanghai Sanyou CARMEN Cervical Fusion System
Shanghai Sanyou Medical Co, LTD   510(k) NO: K163366(Traditional)
ATTN: David  Fan                  PHONE NO : 86 21 58389980 
1988 Jiatang Road                 SE DECISION MADE: 05-OCT-17
Jiading District  CN 201807       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bilicocoon™ Phototherapy System
NEOMEDLIGHT                       510(k) NO: K163526(Traditional)
ATTN: Pierre Saint Girons         PHONE NO : 33 633 902900 
89-90 Rue Frederic FAYS           SE DECISION MADE: 06-OCT-17
Villeurbanne  FR 69100            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantra
HOLOGIC, INC.                     510(k) NO: K163623(Traditional)
ATTN: Neil  Kelly                 PHONE NO : 508 2638634 
36 APPLE RIDGE ROAD               SE DECISION MADE: 20-OCT-17
DANBURY CT  06810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVOS-NAIL Limb Lengthening System (LLS)
Smith & Nephew                    510(k) NO: K163653(Traditional)
ATTN: Allison  Chan               PHONE NO : 901 3991098 
1450 E Brooks Rd.                 SE DECISION MADE: 13-OCT-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Crystal Vision
I.C MEDICAL, INC.                 510(k) NO: K163659(Special)
ATTN: ELENA S. BUIGA              PHONE NO : 623 7800700 
2340 W. SHANGRI LA RD.            SE DECISION MADE: 30-OCT-17
PHOENIX AZ  85029                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SleepImage System
MyCardio, LLC dba SleepImage.     510(k) NO: K163696(Traditional)
ATTN: Robert  Schueppert          PHONE NO : 720 7084209 
370 Interlocken Blvd. Suite 650   SE DECISION MADE: 13-OCT-17
Broomfield CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia Lyme FIA, Sofia Lyme Control Set
Quidel Corporation                510(k) NO: K163713(Traditional)
ATTN: Jennifer S Rial             PHONE NO : 858 5527910 
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 20-OCT-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: High Pressure Tubing
SHANGHAI KINDLY MEDICAL INSTRUMENT510(k) NO: K170014(Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 021 59140056 
NO. 925 JINYUAN YI RD             SE DECISION MADE: 06-OCT-17
SHANGHAI  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Y-Connector Kit
SHANGHAI KINDLY MEDICAL INSTRUMENT510(k) NO: K170024(Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 021 59140056 
NO. 925 JINYUAN YI RD             SE DECISION MADE: 03-OCT-17
SHANGHAI  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Angiography Syringe
SHANGHAI KINDLY MEDICAL INSTRUMENT510(k) NO: K170025(Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 021 59140056 
NO. 925 JINYUAN YI RD             SE DECISION MADE: 03-OCT-17
SHANGHAI  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inflation Device
SHANGHAI KINDLY MEDICAL INSTRUMENT510(k) NO: K170027(Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 021 59140056 
NO. 925 JINYUAN YI RD             SE DECISION MADE: 06-OCT-17
SHANGHAI  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSurg
JACO, LLC dba Macan Manufacturing 510(k) NO: K170054(Abbreviated)
ATTN: John  Marsillo              PHONE NO : 302 6458068 
21 Shay Lane                      SE DECISION MADE: 02-OCT-17
Milton DE  19968                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRENE Cannulated Screw System
TIANJIN ZHENGTIAN MEDICAL INSTRUME510(k) NO: K170056(Traditional)
ATTN: WANG  QI                    PHONE NO : 86 10 82292929 
NO.318, JINGYI ROAD, AIRPORT ECONOSE DECISION MADE: 23-OCT-17
TIANJIN  CN 100082                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
TYSON BIORESEARCH, INC.           510(k) NO: K170079(Traditional)
ATTN: WEN-HAI  TSAI               PHONE NO : 886 375 85988 350
5F, NO. 22, KE E. ROAD III SCIENCESE DECISION MADE: 06-OCT-17
CHU-NAN, MIAO-LI COUNTY  TW 350   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SONON Ultrasound Imaging System, Model: 300L
HEALCERION CO., LTD               510(k) NO: K170085(Traditional)
ATTN: JAEYEOB  JUNG               PHONE NO : 82 707 5826326 
804HO, 38-21, DIGITAL-RO 31-GIL, GSE DECISION MADE: 12-OCT-17
SEOUL  KR 08376                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U-Motion II Acetabular System— Additional sizes
United Orthopedic Corporation     510(k) NO: K170089(Traditional)
ATTN: Gimpel  Chien               PHONE NO : 886 3 5773351 2217
No 57, Park Ave 2, Science Park   SE DECISION MADE: 06-OCT-17
Hsinchu  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyKnee PPS-Pin Positioners
Medacta International SA          510(k) NO: K170106(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 20-OCT-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Galaxy UNYCO System
Orthofix Srl                      510(k) NO: K170146(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via Delle Nazioni 9               SE DECISION MADE: 12-OCT-17
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucica Glycated Albumin-L
ASAHI KASEI PHARMA CORPORATION    510(k) NO: K170147(Traditional)
ATTN: HIDEJI  HIRAOKA             PHONE NO : 81 332 963617 
1-105 KANDA JINBOCHO CHIYODA-KU   SE DECISION MADE: 12-OCT-17
TOKYO  JP 101-8101                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
S.A.L.F. spa                      510(k) NO: K170150(Traditional)
ATTN: Carmelo  Gagliano           PHONE NO : 39 035 940097 
Via Marconi 2                     SE DECISION MADE: 20-OCT-17
Cenate Sotto  IT 24069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Blood Pressure Monitor
Shenzhen Pango Electronic Co., Ltd510(k) NO: K170151(Special)
ATTN: Xiaoyun  Yang               PHONE NO : 86 755 33825988 
No.25, 1st Industrial Park, FenghuSE DECISION MADE: 13-OCT-17
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Creavo Vitalscan Magnetocardiograph
Creavo Medical Technologies, Ltd. 510(k) NO: K170154(Traditional)
ATTN: David  Dimambro             PHONE NO : 44 0 1926670560 
2020 House, Siskin Drive, MiddlemaSE DECISION MADE: 12-OCT-17
Coventry  GB cv3 4fj              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iTotal Family Reusable Instrument Tray
CONFORMIS, INC                    510(k) NO: K170226(Traditional)
ATTN: Emmanuel O. Nyakako         PHONE NO : 781 3459164 
28 CROSBY DRIVE                   SE DECISION MADE: 25-OCT-17
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
BODITECH MED INC.                 510(k) NO: K170232(Traditional)
ATTN: HYUNG-JU  OH                PHONE NO : 82 33 2431400 
43, GEODUDANJI 1-GIL, DONGNAE-MYEOSE DECISION MADE: 13-OCT-17
CHUNCHEON-SI  KR                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
Zhanjiang Star Enterprise Co., Ltd510(k) NO: K170233(Traditional)
ATTN: Rongsheng  Tang             PHONE NO : 86 759 2701619 
NO.1, West Jinhua Rd.             SE DECISION MADE: 13-OCT-17
Zhanjiang  CN 524094              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System
All Medicus Co., Ltd.             510(k) NO: K170241(Traditional)
ATTN: Hong-Joo  Park              PHONE NO : 82 31 4258288 
No. 7102-7107, 7402, 7403, 7406, 1SE DECISION MADE: 13-OCT-17
Anyang-si  KP 14057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premium Plus Prophy Air Motor
PREMIUM PLUS INTERNATIONAL LIMITED510(k) NO: K170261(Abbreviated)
ATTN: JESSICA  MAO                PHONE NO : 852 276 13211 
FLAT 1001 YUEN LONG TRADING CENTRESE DECISION MADE: 19-OCT-17
HONG KONG  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold AQ Blood Glucose Monitoring System
Sinocare Meditech, Inc.           510(k) NO: K170264(Traditional)
ATTN: Qian  Zhou                  PHONE NO : 86 0731 88918123 
No. 265 Guyuan Road, Hi-tech Zone SE DECISION MADE: 05-OCT-17
Changsha  CN 410205               510(k) STATEMENT
                                                    

DEVICE: MSA100BT Peak Flow Meter
Beijing M&B Electronic Instruments510(k) NO: K170281(Traditional)
ATTN: Yang  Shisheng              PHONE NO : 086 010 61253716 8037
No. 27, Yongwang Road, Daxing BioeSE DECISION MADE: 06-OCT-17
Beijing  CN 101102                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Emit II Plus Cocaine Metabolite Assay
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K170293(Traditional)
ATTN: ALAN  HALEY                 PHONE NO : 302 6319883 
P.O. BOX 6101 M/S 514             SE DECISION MADE: 25-OCT-17
NEWARK DE  19714-6101             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liberator Beacon Tip Locking Stylet
Cook Incorporated                 510(k) NO: K170298(Traditional)
ATTN: Steven  Lawrie              PHONE NO : 812 3353575 104518
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 18-OCT-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SunCHECK
SUN NUCLEAR CORPORATION           510(k) NO: K170307(Traditional)
ATTN: RENE  HARDEE                PHONE NO : 321 2596862 2304
3275 SUNTREE BLVD.                SE DECISION MADE: 25-OCT-17
MELBOURNE FL  32940               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
Abbott Laboratories               510(k) NO: K170316(Traditional)
ATTN: Noah  Lermer                PHONE NO : 224 6687613 
Dept. 09AA, Bldg CP1-3, 100 AbbottSE DECISION MADE: 19-OCT-17
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alinity i Total ß-hCG Reagent Kit, Alinity i System
ABBOTT LABORATORIES               510(k) NO: K170317(Traditional)
ATTN: LINDA  SOHN                 PHONE NO : 224 6674846 
DEPT. 09AA, BLDG AP8 100 ABBOTT PASE DECISION MADE: 23-OCT-17
ABBOTT PARK IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low Profile Non-Balloon Feeding Device
APPLIED MEDICAL TECHNOLOGY INC.   510(k) NO: K170319(Traditional)
ATTN: SHRADDHA  SAINI             PHONE NO : 440 7174000 
8006 KATHERINE BOULEVARD          SE DECISION MADE: 06-OCT-17
BRECKSVILLE OH  44141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alinity c ICT Sample Diluent
Abbott Laboratories               510(k) NO: K170320(Traditional)
ATTN: Zaman  Khan                 PHONE NO : 224 6682002 
Dept. 09AA, Bldg CP01-3, 100 AbbotSE DECISION MADE: 24-OCT-17
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tahoe Uni Knee System
Consensus Orthopedics, Inc        510(k) NO: K170344(Traditional)
ATTN: Zac  Johnson                PHONE NO : 916 3557154 
1115 Windfield Way                SE DECISION MADE: 05-OCT-17
El Dorado Hills CA  95762         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOFTDISO
Best Nomos                        510(k) NO: K170345(Traditional)
ATTN: Vineet  Gupta               PHONE NO : 412 3126700 
1 Best Drive                      SE DECISION MADE: 27-OCT-17
Pittsburgh PA  15202              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trinity™ Dual Mobility System
Corin USA Limited                 510(k) NO: K170359(Traditional)
ATTN: Zak  Akhoonjee              PHONE NO : 813 9774469 
5670 W Cypress Street Suite C     SE DECISION MADE: 31-OCT-17
Tampa FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
INTERVENE Group Limited           510(k) NO: K170371(Traditional)
ATTN: Homer  Trieu                PHONE NO : 440 1895 347568 
Russell Building, Brunel Science PSE DECISION MADE: 20-OCT-17
Uxbridge  GB UB8 3PQ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nobilplast Denture Resin
CMP Industries LLC                510(k) NO: K170375(Traditional)
ATTN: Devon O. Howe               PHONE NO : 1 518 4343147 128
413 N. Pearl St.                  SE DECISION MADE: 02-OCT-17
Albany NY  12207                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kisses Mini
ACHIMHAI Medical Corporation      510(k) NO: K170394(Traditional)
ATTN: Ji Ho  Jung                 PHONE NO : 82 70 42964318__ 
28, Namyang-ro, 930beon-gil, NamyaSE DECISION MADE: 06-OCT-17
Hwaseong-si  KR 18255             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DentureID Microchip
CMP Industries LLC                510(k) NO: K170423(Traditional)
ATTN: Devon O. Howe               PHONE NO : 1 518 4343147 128
413 N. Pearl St.                  SE DECISION MADE: 25-OCT-17
Albany NY  12207                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AN85/AN86 EO Indicators
Andersen Sterilizers,Inc.         510(k) NO: K170426(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 30-OCT-17
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anprolene SteriTest
Andersen Sterilizers,Inc.         510(k) NO: K170427(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 31-OCT-17
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyvek Sterilization Pouches with Chevron Seal
Andersen Sterilizers, Inc.        510(k) NO: K170429(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 27-OCT-17
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anprolene AN75 Ethylene Oxide Gas Sterilizer
Andersen Sterilizers, Inc.        510(k) NO: K170432(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 31-OCT-17
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medacta Shoulder System
Medacta International SA          510(k) NO: K170452(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 916 966060 
Strada Regina                     SE DECISION MADE: 05-OCT-17
Castel San Pietro  CH ch-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medrobotics Flex Robotic System
Medrobotics Corporation           510(k) NO: K170453(Traditional)
ATTN: John D. Bonasera            PHONE NO : 508 6926460 
475 Paramount Drive               SE DECISION MADE: 19-OCT-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
Honsun(Nantong) Co., Ltd.         510(k) NO: K170454(Traditional)
ATTN: Selina  Qian                PHONE NO : 86 051 380580022 
No.8,Tongxing Road, Nantong EconomSE DECISION MADE: 25-OCT-17
Nantong  CN 226009                510(k) STATEMENT
                                                    

DEVICE: Automatic Blood Pressure Monitor Model LD-518 & LD-537
Honsun(Nantong) Co., Ltd.         510(k) NO: K170466(Traditional)
ATTN: Selina  Qian                PHONE NO : 86 51 380580022 
No.8,Tongxing Road, Nantong EconomSE DECISION MADE: 27-OCT-17
Nantong  CN 226009                510(k) STATEMENT
                                                    

DEVICE: Digital Eye Anterior Camera
Medimaging Integrated Solution Inc510(k) NO: K170470(Traditional)
ATTN: Yi-Ying  Chen               PHONE NO : 886 357 98860 1290
1F, No.7, R&D Rd. II Hsinchu ScienSE DECISION MADE: 06-OCT-17
Hsinchu  TW 30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG Check - Universal, ECG Check - Universal Plus
Cardiac Designs, Inc.             510(k) NO: K170506(Traditional)
ATTN: James  Tassone              PHONE NO : 844 3242432 
25510 Interstate 45 N Suite 202   SE DECISION MADE: 02-OCT-17
Spring TX  77386                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RVS-100 Vital Signs Monitor
Rudolf Riester GmbH               510(k) NO: K170538(Traditional)
ATTN: Christof  Kleiner           PHONE NO : 49 7477 927043 
P.O.B. 35, Bruckstraße 31         SE DECISION MADE: 17-OCT-17
Jungingen  DE 72417               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InSure ONE
Enterix Inc.                      510(k) NO: K170548(Traditional)
ATTN: Michele  Houldsworth        PHONE NO : 732 4291899 
236 Fernwood Avenue               SE DECISION MADE: 05-OCT-17
Edison NJ  08837                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Skylife
NeoLight, LLC                     510(k) NO: K170585(Traditional)
ATTN: Sivakumar  Palaniswamy      PHONE NO : 480 7549681 
1475 N Scottsdale Rd, Suite 200   SE DECISION MADE: 27-OCT-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERILE VINYL EXAMINATION GLOVES, Powder Free
Primus Gloves PVT Limited         510(k) NO: K170612(Traditional)
ATTN: Jose  Paul M                PHONE NO : 91 484 2413063 
Plot No 14A, Cochin Special EconomSE DECISION MADE: 23-OCT-17
Cochin  IN 682037                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K170614(Special)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100453 
43,Banpo-daero 82-gil, Seocho-gu  SE DECISION MADE: 19-OCT-17
Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeSept Transseptal Guidewire
Pressure Products Medical Device M510(k) NO: K170671(Traditional)
ATTN: Andrew  Armour              PHONE NO : 610 5432324 
1 School Street                   SE DECISION MADE: 20-OCT-17
Morton PA  19070                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tamper Evident Cap For use with ENFit Syringes
International Medical Industries, 510(k) NO: K170672(Traditional)
ATTN: Brandon  Hunt               PHONE NO : 954 9179570 
2981 Gateway Drive                SE DECISION MADE: 06-OCT-17
Pompano Beach FL  33069           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap 3D Imaging and Mapping Catheter
Acutus Medical, Inc.              510(k) NO: K170819(Traditional)
ATTN: Brenda  Clay                PHONE NO : 1 442 2326080 
2210 Faraday Ave., Ste 100        SE DECISION MADE: 16-OCT-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CERABIEN ZR
Kuraray Noritake Dental Inc.      510(k) NO: K170834(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011736 
Ote Center Bldg. 7F               SE DECISION MADE: 17-OCT-17
Chiyoda-ku  JP 100-0004           510(k) STATEMENT
                                                    

DEVICE: MAGNETOM Terra
Siemens Medical Solutions USA, Inc510(k) NO: K170840(Traditional)
ATTN: Milind  Dhamankar           PHONE NO : 610 4486447 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 12-OCT-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
SwissMediTec GmbH                 510(k) NO: K170873(Traditional)
ATTN: Kurosh  Sohi                PHONE NO : 41 41 4810086 
Gfellen 26                        SE DECISION MADE: 02-OCT-17
Finsterwald  CH 6162              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bi-Ostetic Bioactive Glass Foam
Berkeley Advanced Biomaterials    510(k) NO: K170917(Traditional)
ATTN: François  Génin             PHONE NO : 510 8830500 
901 Grayson Street, Suite 101     SE DECISION MADE: 30-OCT-17
Berkeley CA  94710                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.              510(k) NO: K170948(Traditional)
ATTN: Brenda  Clay                PHONE NO : 442 2326080 
2210 Faraday Ave., Suite 100      SE DECISION MADE: 16-OCT-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monosyn Quick Synthetic Absorbable Surgical Suture
Aesculap, Inc.                    510(k) NO: K171001(Traditional)
ATTN: Kathy A. Racosky            PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 23-OCT-17
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anorganic Bone Mineral with Collagen in Delivery Applicator
Collagen Matrix, Inc.             510(k) NO: K171008(Traditional)
ATTN: Danielle  Lindner           PHONE NO : 201 4051477 
15 Thornton Road                  SE DECISION MADE: 30-OCT-17
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VICTUS Femtosecond Laser Platform
Technolas Perfect Vision GmbH     510(k) NO: K171014(Traditional)
ATTN: Friedrich  Moritz           PHONE NO : 49 89 94004494 
Messerschmittstr. 1+3             SE DECISION MADE: 19-OCT-17
Munich  DE 80992                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Citryte
Di-Chem, Inc.                     510(k) NO: K171015(Traditional)
ATTN: Keith  Buchholz             PHONE NO : 763 4228311 
12297 Ensign Avenue North         SE DECISION MADE: 13-OCT-17
Champlin MN  55316                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
Convaid Products llc.             510(k) NO: K171017(Traditional)
ATTN: Donald  Griggs              PHONE NO : 310 6180111 
2830 California St                SE DECISION MADE: 18-OCT-17
Torrance CA  90503                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultimate Contour, Ultimate Contour Mini
CAO Group, Inc.                   510(k) NO: K171052(Traditional)
ATTN: Robert K. Larsen            PHONE NO : 801 2569282 
4628 West Skyhawk Drive           SE DECISION MADE: 20-OCT-17
West Jordan UT  84084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoView 7.2
Meridian Technique Ltd            510(k) NO: K171068(Third Party - Traditional)
ATTN: Barbara  March              PHONE NO : 440 2380 762500 
2 Venture Road, Southampton SciencSE DECISION MADE: 18-OCT-17
Southhampton  GB SO16 7NP         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Senhance Surgical Robotic System
TransEnterix, Inc.                510(k) NO: K171120(Traditional)
ATTN: Stephanie  Fitts            PHONE NO : 1 919 7658430 
635 Davis Drive, Suite 300        SE DECISION MADE: 13-OCT-17
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Tangible Science LLC              510(k) NO: K171125(Traditional)
ATTN: Vic  McCray                 PHONE NO : 1 650 2411045 
173 Jefferson Drive               SE DECISION MADE: 18-OCT-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healing Cap Multi-Unit Titanium
Nobel Biocare AB                  510(k) NO: K171142(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 26-OCT-17
Goteborg  SE se-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquarius 8600 1417TG and Aquarius 8600 1717TG
Imaging Dynamics Company Ltd.     510(k) NO: K171169(Special)
ATTN: Nicole  Wherry              PHONE NO : 403 2519939 
#130, 5310-29th Street NE         SE DECISION MADE: 12-OCT-17
Calgary  CA T1Y 7E5               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquarius 8600 1417WC
Imaging Dynamics Company Ltd.     510(k) NO: K171175(Special)
ATTN: Nicole  Wherry              PHONE NO : 403 2519939 
#130, 5310-29th Street NE         SE DECISION MADE: 05-OCT-17
Calgary  CA T1Y 7E5               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ri-former Predictive Thermometer
Rudolf Riester GmbH               510(k) NO: K171182(Traditional)
ATTN: Artur  Pfister              PHONE NO : 74 779 2700 
P.O.B. 35, Bruckstraße 31         SE DECISION MADE: 04-OCT-17
Junginge  DE DE-72417             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D'Vill Introducer
NuMED, Inc.                       510(k) NO: K171206(Traditional)
ATTN: Nichelle  LaFlesh           PHONE NO : 315 3284491 
2880 Main Street                  SE DECISION MADE: 20-OCT-17
Hopkinton NY  12965               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: audifon Tinnitus-Module
audiofon USA Inc.                 510(k) NO: K171243(Abbreviated)
ATTN: Jane E. Perrone             PHONE NO : 386 6688812 
403 Chairman CT., Suite 1         SE DECISION MADE: 19-OCT-17
Debary FL  32713                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRIDALVEIL Occipital Cervical Thoracic System
Astura Medical                    510(k) NO: K171250(Traditional)
ATTN: Troy  Taylor                PHONE NO : 760 8148047 
3186 Lionshead Ave, Suite 100     SE DECISION MADE: 02-OCT-17
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint System
MRI Interventions, Inc.           510(k) NO: K171257(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 20-OCT-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K171277(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5255972 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 23-OCT-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
Top Glove SDN BHD                 510(k) NO: K171279(Traditional)
ATTN: Noor Akilah  Bt Saidin      PHONE NO : 603 3392 1992 
Lot 4968, Jalan Teratai, Batu 6, OSE DECISION MADE: 12-OCT-17
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: PAL Multi-Use Cannulas and PAL Manual Wand
MicroAire Surgical Instruments, LL510(k) NO: K171286(Traditional)
ATTN: Glenn  Gerstenfeld          PHONE NO : 434 9758344 
3590 Grans Forks Blvd             SE DECISION MADE: 13-OCT-17
Charlottesville VA  22911         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G3™ Active Plate® Miniature System
Genesis Fracture Care, Inc.       510(k) NO: K171293(Traditional)
ATTN: Michael  Bottlang           PHONE NO : 503 5284048 
13568 SE 97th Ave., Suite 202     SE DECISION MADE: 23-OCT-17
Clackamas OR  97015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Bair Hugger Model 675 Total Temperature Management System
3M Company                        510(k) NO: K171373(Traditional)
ATTN: Jon  Platt                  PHONE NO : 651 7361850 
3M Center, Building 275-5W-06     SE DECISION MADE: 10-OCT-17
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sienna Ultimate Wireless Amplifier
EMS Handels Gesellschaft m.b.H.   510(k) NO: K171397(Traditional)
ATTN: Ruzena  Ortnerova           PHONE NO : 43 2262 616550 
Jochingergasse 1                  SE DECISION MADE: 06-OCT-17
Korneuburg  AT A-2100             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acapella Cervical Spacer System
Choice Spine, LP.                 510(k) NO: K171489(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 23-OCT-17
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2P Destination Slender Guiding Sheath
Terumo Medical Corporation        510(k) NO: K171491(Traditional)
ATTN: Liang  Lu                   PHONE NO : 410 3927321 
950 Elkton Blvd                   SE DECISION MADE: 05-OCT-17
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mikron Spinal Fixation System
Mikron Makina Sanayi Ticaret Co. L510(k) NO: K171497(Traditional)
ATTN: Mesut  KOSE                 PHONE NO : 90 532 4418629 
Agac Isleri Sanayi Sitesi 1372. SoSE DECISION MADE: 12-OCT-17
Ankara  TR 06378                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed CristaCath Diagnostic Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K171503(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5255972 
1435 North Hayden Road Suite 100  SE DECISION MADE: 05-OCT-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intellijoint HIP Generation 2B System
Intellijoint Surgical Inc.        510(k) NO: K171525(Traditional)
ATTN: Brandon  Gingrich           PHONE NO : 1 519 3423178 
60 Bathurst Drive Unit 6          SE DECISION MADE: 30-OCT-17
Waterloo  CA N2V 2A9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
Wilson-Cook Medical, Inc.         510(k) NO: K171548(Traditional)
ATTN: Sierra  Lowe                PHONE NO : 336 7440157 396506
4900 Bethania Station Road        SE DECISION MADE: 13-OCT-17
Winston-Salem NC  57105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENFLU 18 (enflufocon A) Daily Wear Contact Lens
CONTAMAC Ltd.                     510(k) NO: K171575(Traditional)
ATTN: Rob  Mcgregor               PHONE NO : 44 1799 542000 
Carlton House Shire Hill          SE DECISION MADE: 24-OCT-17
Saffron Walden  GB CB11 3AU       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171579(Traditional)
ATTN: Yang  ZhaoHui               PHONE NO : 86 755 81885640 
Mindray Building, Keji 12th Road SSE DECISION MADE: 18-OCT-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode RF System
InMode MD Ltd.                    510(k) NO: K171593(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 490 97470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 10-OCT-17
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accuro
Rivanna Medical, LLC              510(k) NO: K171594(Traditional)
ATTN: William  Mauldin            PHONE NO : 800 6457508 701
107 E Water St                    SE DECISION MADE: 20-OCT-17
Charlottesville VA  22902         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M-ARS ACL: Anatomic Ribbon Surgery System
Medacta International SA          510(k) NO: K171640(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 23-OCT-17
Castel San Pietro  CH ch-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
Geistlich Pharma AG               510(k) NO: K171643(Traditional)
ATTN: Marco  Steiner              PHONE NO : 011 41 414926764 
Bahnhofstrasse 40                 SE DECISION MADE: 30-OCT-17
Wolhusen  CH ch- 6110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeneLife Premium Facial Treatment Pack, Model: QZ0701A
Infinitus (China) Company Ltd.    510(k) NO: K171647(Traditional)
ATTN: Judy  Zhou                  PHONE NO : 86 020 80734648 
17/F, Infinitus Centre, No.12 ZhujSE DECISION MADE: 23-OCT-17
Guangzhou  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 065 Zenith, 074 Zenith
InNeuroCo, Inc                    510(k) NO: K171672(Traditional)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 19-OCT-17
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K171689(Traditional)
ATTN: Kelly  Anglin               PHONE NO : 901 3992018 
1800 Pyramid Place                SE DECISION MADE: 05-OCT-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exciplex308nm
Clarteis                          510(k) NO: K171702(Traditional)
ATTN: Laurent  Meilhac            PHONE NO : 33 9 54039377 
WTC2, 120 route des macarons      SE DECISION MADE: 13-OCT-17
Valbonne  FR 06 560               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALOKA ARIETTA 850
Hitachi Healthcare Americas Corpor510(k) NO: K171708(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 9630749 
1959 Summit Commerce Park         SE DECISION MADE: 31-OCT-17
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BR-FHUS Viewer 1.0
TaiHao Medical Inc.               510(k) NO: K171709(Traditional)
ATTN: Hsin Hung (Simon) Lai       PHONE NO : 886 2 27365679 
3F.-8, No.100, Sec. 2 Heping E. RdSE DECISION MADE: 20-OCT-17
Taipei  TW 10663                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
Capsule Technologie, SAS          510(k) NO: K171751(Third Party - Traditional)
ATTN: James  Hodge                PHONE NO : 978 4822300 
300 Brickstone Square             SE DECISION MADE: 24-OCT-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: X-SURGE
Genicon, Inc                      510(k) NO: K171752(Special)
ATTN: Katlyn  Kachman             PHONE NO : 407 6574851 614
6869 Stapoint Court Suite 114     SE DECISION MADE: 17-OCT-17
Winter Park FL  32792             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden CO2 Monitor
Nihon Kohden Corporation          510(k) NO: K171765(Traditional)
ATTN: Thomas  Bento               PHONE NO : 949 6809048 
1-31-4 Nishiochiai, Shinjuku-Ku   SE DECISION MADE: 11-OCT-17
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cianna Medical SAVI Scout Reflector and SAVI Scout System
Cianna Medical, Inc.              510(k) NO: K171767(Traditional)
ATTN: Gary  Mocnik                PHONE NO : 949 3600059 134
6 Journey, Suite 125              SE DECISION MADE: 31-OCT-17
Aliso Viejo CA  92656             510(k) STATEMENT
                                                    

DEVICE: Trident® II Acetabular System
Howmedica Osteonics Corp. aka Stry510(k) NO: K171768(Traditional)
ATTN: Valerie  Giambanco          PHONE NO : 201 8316275 
325 Corporate Drive               SE DECISION MADE: 02-OCT-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RPM Reinforced PTFE Mesh
Osteogenics Biomedical, Inc.      510(k) NO: K171774(Traditional)
ATTN: Shane  Shuttlesworth        PHONE NO : 806 7961923 
4620 71st St. Bldg. 78-79         SE DECISION MADE: 19-OCT-17
Lubbock TX  79424                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
Blue Sail Medical Co.,Ltd         510(k) NO: K171782(Traditional)
ATTN: Robin  Liu                  PHONE NO : 86 533 7871217 
No. 21 Qingtian Road, Qilu ChemicaSE DECISION MADE: 12-OCT-17
Zibo  CN 255414                   510(k) STATEMENT
                                                    

DEVICE: Vial Adapter 15mm
Medimop Medical Project Ltd.      510(k) NO: K171796(Special)
ATTN: Jeffrey  Ravel              PHONE NO : 972 977 57122 
17 Hatidhar St                    SE DECISION MADE: 12-OCT-17
Ra'anana  IL 43665                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
Philips Medizin Systeme Boeblingen510(k) NO: K171801(Abbreviated)
ATTN: Markus  Stacha              PHONE NO : 49 7031 4632840 
Hewlett-Packard-Str.-2            SE DECISION MADE: 06-OCT-17
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra-Lock Bone Fixation System
Intra-Lock International, Inc.    510(k) NO: K171831(Traditional)
ATTN: Mary L. Jean                PHONE NO : 561 4478282 
6560 West Rogers Circle Bldg 24   SE DECISION MADE: 26-OCT-17
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
HARTALEGA SDN. BHD.               510(k) NO: K171874(Traditional)
ATTN: KUAN  KAM HON               PHONE NO : 603 6277 1733 
DATARAN SD PJU 9                  SE DECISION MADE: 12-OCT-17
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: HylaGuard Moisturizing Cream
Founders Science Group, LLC       510(k) NO: K171879(Traditional)
ATTN: Ronald M. Gurge             PHONE NO : 508 2588055 
30 Robert W. Boyden Road Suite A10SE DECISION MADE: 16-OCT-17
Taunton MA  02780                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cortina™ Lumbar Cage System
NeuroStructures, Inc.             510(k) NO: K171914(Traditional)
ATTN: Kathleen  Wong              PHONE NO : 949___ 3704497 
16 Technology Drive, Suite 165    SE DECISION MADE: 25-OCT-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Hot Biopsy Forceps FD-231
Olympus Medical Systems Corp.     510(k) NO: K171916(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 13-OCT-17
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C5 Diagnostic Ultrasound System
Guangzhou Sonostar Technologies Co510(k) NO: K171926(Traditional)
ATTN: Weizhong  Cai               PHONE NO : 086 20 32382095 
504#, C Building, #27 Yayingshi RoSE DECISION MADE: 27-OCT-17
Guangzhou  CN 510665              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity ECG Cable Accessory Pack
Medcomp (Medical Components, Inc.)510(k) NO: K171931(Traditional)
ATTN: Colton  Muraira             PHONE NO : 215 2564201 2305
1499 Delp Dr.                     SE DECISION MADE: 26-OCT-17
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
Medtronic                         510(k) NO: K171938(Traditional)
ATTN: Lee  Grant                  PHONE NO : 901 3440807 
1800 Pyramid Place                SE DECISION MADE: 23-OCT-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gel-Bead
Vascular Solutions, Inc.          510(k) NO: K171946(Special)
ATTN: Lisa  Gallatin              PHONE NO : 763 6564300 
6464 Sycamore Court North         SE DECISION MADE: 25-OCT-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solana RSV+hMPV Assay
Quidel Corporation                510(k) NO: K171974(Traditional)
ATTN: Ronald H. Lollar            PHONE NO : 1 740 5893373 
2005 East State Street, Suite 100 SE DECISION MADE: 16-OCT-17
Athens OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
Shenzhen Dongdixin Technology Co.,510(k) NO: K171978(Traditional)
ATTN: Siping  Yuan                PHONE NO : 86 755 27652471 
No. 3 Building Xilibaimang XushengSE DECISION MADE: 02-OCT-17
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tubing Pack
Medtronic, Inc.                   510(k) NO: K171979(Special)
ATTN: Renee  Cveykus              PHONE NO : 763 5053059 
8200 Coral Sea Street NE (MVS83)  SE DECISION MADE: 27-OCT-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clickfine Pen Needle, Penfine Classic Pen Needle
Ypsomed AG                        510(k) NO: K171984(Special)
ATTN: Stephan  Affolter           PHONE NO : 0041 34 4243382 
Brunnmattstrasse 6                SE DECISION MADE: 11-OCT-17
Burgdorf  CH CH- 3401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Lucenxia Prescience AG            510(k) NO: K171987(Special)
ATTN: Robert  Hill                PHONE NO : 41 41 7689126 
Rathausstrasse  7                 SE DECISION MADE: 20-OCT-17
Baar  CH 6341                     510(k) STATEMENT
                                                    

DEVICE: EMPOWR Porous Knee System
Encore Medical, L.P.              510(k) NO: K171991(Traditional)
ATTN: Desiree  Wells              PHONE NO : 512 8346302 
9800 Metric Blvd.                 SE DECISION MADE: 04-OCT-17
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruWave Disposable Pressure Transducer
Edwards Lifesciences, LLC         510(k) NO: K171996(Traditional)
ATTN: Renate A. MacLaren          PHONE NO : 949 2505783 
One Edwards Way                   SE DECISION MADE: 23-OCT-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLumen II Peripheral Thrombectomy System
Walk Vascular, LLC                510(k) NO: K172000(Traditional)
ATTN: David  Look                 PHONE NO : 949 7529642 
17171 Daimler Street              SE DECISION MADE: 24-OCT-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Force Fiber Fusion Suture
Teleflex Medical Incorporated     510(k) NO: K172016(Traditional)
ATTN: Vladislava  Zaitseva        PHONE NO : 508 9646030 
375 Forbes Boulevard              SE DECISION MADE: 03-OCT-17
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Codman & Shurtleff, Inc.          510(k) NO: K172022(Traditional)
ATTN: Christopher  Garete         PHONE NO : 508 9773869 
325 Paramount Drive               SE DECISION MADE: 03-OCT-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CELFIRM
VIOL Co., Ltd.                    510(k) NO: K172023(Traditional)
ATTN: Jongju  Na                  PHONE NO : 82 31 80177893 
C-808, 809, Bundang Technopark C,7SE DECISION MADE: 13-OCT-17
Seongnam-si  KR 13510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adani MammoScan
ADANI                             510(k) NO: K172027(Traditional)
ATTN: Vladimir  Klokov            PHONE NO : 37 52 92145846 
Selitski St., 7                   SE DECISION MADE: 20-OCT-17
Minsk  BY 220075                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
Gebauer Company                   510(k) NO: K172028(Traditional)
ATTN: Brittney  Schmies           PHONE NO : 216 5813030 
4444 East 153rd Street            SE DECISION MADE: 27-OCT-17
Cleveland OH  44128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
Stryker Corporation               510(k) NO: K172034(Traditional)
ATTN: Andrea  Wallen-Gerding      PHONE NO : 1 269 3892884 
Boetzinger Strasse 41             SE DECISION MADE: 18-OCT-17
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trocar
WickiMed (Huizhou) Medical Equipme510(k) NO: K172038(Traditional)
ATTN: Haobin  Li                  PHONE NO : 86 075 23860807 
Tang Jiao Wang Street, Lilin Town SE DECISION MADE: 27-OCT-17
Huizhou  CN 516000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LinkQuest Diagnostic Ultrasound System model SQ860
LinkQuest Inc.                    510(k) NO: K172059(Traditional)
ATTN: Xiaolong  Yu                PHONE NO : 858 6239916 
6749 Top Gun Street #100          SE DECISION MADE: 05-OCT-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cutera enlighten III Laser System
Cutera, Inc.                      510(k) NO: K172077(Traditional)
ATTN: Bradley  Renton             PHONE NO : 415 6575568 
3240 Bayshore Blvd.               SE DECISION MADE: 27-OCT-17
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avail
Omron Healthcare, Inc.            510(k) NO: K172079(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court             SE DECISION MADE: 19-OCT-17
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SANGRAY
Hitachi Ltd.                      510(k) NO: K172087(Traditional)
ATTN: Kazuaki  Tsuchiya           PHONE NO : 81 471 314159 
2-1, Shintoyofuta                 SE DECISION MADE: 27-OCT-17
Kashiwa-Shi  JP 277-0804          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROLENE Soft Polypropylene Mesh
Ethicon, Inc.                     510(k) NO: K172089(Traditional)
ATTN: Stephanie  Saati            PHONE NO : 908 2183318 
Route 22 West, P.O. Box 151       SE DECISION MADE: 05-OCT-17
Somerville NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GuideLiner V3 Catheter
Vascular Solutions, Inc.          510(k) NO: K172090(Traditional)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 20-OCT-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Shavers/Burs
Renovo, Inc.                      510(k) NO: K172092(Traditional)
ATTN: Mark K. Wells               PHONE NO : 1 541 4228880 
340 SW Columbia St.               SE DECISION MADE: 04-OCT-17
Bend OR  97702                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Covidien Trocar
Renovo, Inc.                      510(k) NO: K172093(Traditional)
ATTN: Mark K. Wells               PHONE NO : 541 4228880 
340 SW Columbia St.               SE DECISION MADE: 05-OCT-17
Bend OR  97702                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
Renovo, Inc.                      510(k) NO: K172097(Traditional)
ATTN: Mark K. Wells               PHONE NO : 1 541 4228880 
340 SW Columbia St.               SE DECISION MADE: 06-OCT-17
Bend OR  97702                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shoocin Introducer Kit
Lepu Medical Technology (Beijing) 510(k) NO: K172099(Traditional)
ATTN: Xiangdan  Jin               PHONE NO : 86 10 80123510 
No. 37 Chaoqian Road              SE DECISION MADE: 05-OCT-17
Beijing  CN 102200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U by Kotex Click Unscented Menstrual Tampons
Kimberly-Clark Corporation        510(k) NO: K172118(Traditional)
ATTN: Charnelle  Thomas           PHONE NO : 678 3526031 
2100 Winchester Road              SE DECISION MADE: 11-OCT-17
Neenah WI  54956                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Modulus XLIF Interbody System
NuVasive, Incorporated            510(k) NO: K172123(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Blvd.                   SE DECISION MADE: 11-OCT-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CleanCision Wound Retraction and Protection System
Prescient Surgical, Inc.          510(k) NO: K172132(Traditional)
ATTN: Lisa  Claude                PHONE NO : 650 9990263 
1585 Industrial Rd.               SE DECISION MADE: 25-OCT-17
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
Axis-Shield Diagnostics Ltd.      510(k) NO: K172133(Special)
ATTN: Claire  Dora                PHONE NO : 44 0 1382422000 
Luna Place The Technology Park    SE DECISION MADE: 27-OCT-17
Dundee  GB dd2 1xa                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture,  FILAPROP - Non Absorbable Polypropylene surgical Suture
M/s. Meril Endo Surgery Private Li510(k) NO: K172149(Special)
ATTN: Umesh  Sharma               PHONE NO : 91 0260 3052100 
Third Floor, E1-E3, Meril Park, SuSE DECISION MADE: 20-OCT-17
Chala, Vapi  IN 396191            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips IntelliSite Pathology Solution
Philips Medical Systems Nederland 510(k) NO: K172174(Abbreviated)
ATTN: Esther  Abels               PHONE NO : 31 6 21846515__ 
Veenpluis 4-6                     SE DECISION MADE: 04-OCT-17
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Chitogel Endoscopic Sinus Surgery Kit
Chitogel Ltd                      510(k) NO: K172179(Traditional)
ATTN: Caty  Spencer               PHONE NO : 64 21 969149 
139 Moray Place                   SE DECISION MADE: 17-OCT-17
Dunedin  NZ 9016                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: micro IPL
EL Global Trade Ltd               510(k) NO: K172181(Traditional)
ATTN: Yael  Liebes                PHONE NO : 972 9 7889067 
8 Tzoran St, P.O.Box 8242         SE DECISION MADE: 13-OCT-17
Netanya  IL 4250608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioWick X Implant with Driver
Cayenne Medical, Inc.             510(k) NO: K172186(Traditional)
ATTN: Shima  Hashemian            PHONE NO : 480 5023661 
16597 N. 92nd Street, Suite 101   SE DECISION MADE: 16-OCT-17
Scottsdale AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion Prime SP, TSX-303B/1, v8.4
Toshiba Medical Systems Coroporati510(k) NO: K172188(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 06-OCT-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
ORIGIO a/s                        510(k) NO: K172197(Traditional)
ATTN: Tove  Kjaer                 PHONE NO : 45 4679 0220 
Knardrupvej 2                     SE DECISION MADE: 13-OCT-17
Malov  DK 2760                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 585
Quanta System S.p.A.              510(k) NO: K172198(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 367815 
Via Acquedotto, 109               SE DECISION MADE: 17-OCT-17
Samarate  IT 21017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3880 MRI Patient Monitoring System
Iradimed Corporation              510(k) NO: K172200(Traditional)
ATTN: Francis  Casey              PHONE NO : 407 6778022 
1025 Willa Springs Dr             SE DECISION MADE: 25-OCT-17
Winter Springs FL  32708          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
Nuance Medical, LLC               510(k) NO: K172203(Traditional)
ATTN: Marc  Lieberman             PHONE NO : 760 5854849 
5931 Sea Lion Place, Suite 113    SE DECISION MADE: 18-OCT-17
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker Trauma AG                 510(k) NO: K172210(Traditional)
ATTN: Tina  Mornak                PHONE NO : 201 8316365 
325 Corporate Drive               SE DECISION MADE: 02-OCT-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MECRON Cannulated Screw System
Merete GmbH                       510(k) NO: K172213(Traditional)
ATTN: Paul  Munch                 PHONE NO : 49 30 7799800 
Alt-Lankwitz 102                  SE DECISION MADE: 23-OCT-17
Berlin  DE 12247                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
Avinger, Inc.                     510(k) NO: K172236(Special)
ATTN: Thomas  Lawson              PHONE NO : 650 2417004 
400 Chesapeake Drive              SE DECISION MADE: 30-OCT-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UTS Stem
United Orthopedic Corporation     510(k) NO: K172251(Traditional)
ATTN: Gimpel  Chien               PHONE NO : 886 3 5773351 2217
No 57, Park Ave 2, Science Park   SE DECISION MADE: 24-OCT-17
Hsinchu  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lyme B. burgdorferi (IgM) MarStripe Test
Trinity Biotech                   510(k) NO: K172254(Traditional)
ATTN: Kevin  Lawson               PHONE NO : 716 6910091 
60 Pineview Dr.                   SE DECISION MADE: 23-OCT-17
Buffalo NY  14031                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iFuse Implant System- iFuse Navigation
SI-BONE, Inc.                     510(k) NO: K172268(Traditional)
ATTN: Roxanne  Dubois             PHONE NO : 408 2070700 2236
3055 Olin Avenue, Suite 2200      SE DECISION MADE: 31-OCT-17
San Jose CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PuRE PMMA Disc
Quest Dental USA Corp.            510(k) NO: K172281(Traditional)
ATTN: Hirotaka  Mori              PHONE NO : 949 8703985 
17865 Sky Park Circle Suite L1    SE DECISION MADE: 19-OCT-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panther Fusion Paraflu Assay
Hologic, Inc.                     510(k) NO: K172282(Traditional)
ATTN: Jeffrey  Hergesheimer       PHONE NO : 1 858 4108536 
10210 Genetic Center Drive        SE DECISION MADE: 23-OCT-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ablatherm Fusion
EDAP TECHNOMED, INC.              510(k) NO: K172285(Traditional)
ATTN: Hugo  Embert                PHONE NO : 512 8327956 
5321 Industrial Oaks Blvd, Suite 1SE DECISION MADE: 03-OCT-17
Austin TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
Q Urological Corporation          510(k) NO: K172289(Special)
ATTN: Scott  Epstein              PHONE NO : 781 4490022 
15 Kearney Road                   SE DECISION MADE: 04-OCT-17
Needham MA  02492                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stethee Pro
M3dicine Pty. Ltd.                510(k) NO: K172296(Third Party - Traditional)
ATTN: Nayyar  Hussain             PHONE NO : 61 7 38415148 
1389 Beenleigh Road               SE DECISION MADE: 30-OCT-17
Brisbane  AU 4112                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NovaCross Microcatheter
Nitiloop Ltd.                     510(k) NO: K172297(Special)
ATTN: Chanan  Schneider           PHONE NO : 972 9 7904600 
4 Ha'Omanut Street                SE DECISION MADE: 18-OCT-17
Netanya  IL 4250438               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Datascope Corp.                   510(k) NO: K172305(Special)
ATTN: Helder A. Sousa             PHONE NO : 973 7097465 
1300 MacArthur Blvd.              SE DECISION MADE: 12-OCT-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynamic Coronary Roadmap 2.0
Philips Medical Systems Nederland 510(k) NO: K172307(Abbreviated)
ATTN: Laura  Wortel               PHONE NO : 31 646 801015 
Veenpluis 4-6                     SE DECISION MADE: 24-OCT-17
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnia Medical VBR
Omnia Medical, LLC                510(k) NO: K172323(Traditional)
ATTN: Troy  Schifano              PHONE NO : 304 4134851 
1000 Hampton Center Suite G       SE DECISION MADE: 26-OCT-17
Morgantown WV  26505              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rhapsody H-30 Holmium Laser System
Cook Incorporated                 510(k) NO: K172325(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 Daniels Way P.O. Box 489      SE DECISION MADE: 26-OCT-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
Stryker Orthopaedics              510(k) NO: K172326(Traditional)
ATTN: Margaret  Klippel           PHONE NO : 1 201 8315559 
325 Corporate Drive               SE DECISION MADE: 30-OCT-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sysmex CS-5100
Siemens Healthcare Diagnostics Pro510(k) NO: K172333(Traditional)
ATTN: Donna  Noeh                 PHONE NO : 49 6421 395107 
Emil-von-Behring Strasse 76       SE DECISION MADE: 31-OCT-17
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortus™ Expandable Lumbar Interbody Fusion System
Atlas Spine, Inc.                 510(k) NO: K172334(Traditional)
ATTN: Thomas  Smith               PHONE NO : 561 7411108 
1555 Jupiter Park Drive, Suite 1  SE DECISION MADE: 25-OCT-17
Jupiter FL  33458                 510(k) STATEMENT
                                                    

DEVICE: NuVasive® Modulus TLIF Interbody System
NuVasive, Incorporated            510(k) NO: K172341(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Boulevard               SE DECISION MADE: 26-OCT-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
RTI Surgical, Inc.                510(k) NO: K172343(Traditional)
ATTN: Diana  Taylor               PHONE NO : 386 4188888 4384
11621 Research Circle             SE DECISION MADE: 23-OCT-17
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
Encore Medical, L.P.              510(k) NO: K172351(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd                  SE DECISION MADE: 30-OCT-17
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TREFOIL System
Nobel Biocare AB                  510(k) NO: K172352(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 20-OCT-17
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery Pico, Discovery Pico Plus
Quanta System S.p.A.              510(k) NO: K172376(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 033 1376797 
Via Acquedotto, 109               SE DECISION MADE: 19-OCT-17
Samarate  IT 20826                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroMatrix
ACell, Inc.                       510(k) NO: K172399(Traditional)
ATTN: Salman  Elmi                PHONE NO : 410 9538509 
6640 Eli Whitney Drive, Suite 200 SE DECISION MADE: 06-OCT-17
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Luminex Corporation               510(k) NO: K172402(Traditional)
ATTN: Jennifer  Grimes            PHONE NO : 416 5934323 42281
12212 Technology Blvd.            SE DECISION MADE: 30-OCT-17
Austin TX  78727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GSI Novus
Grason-Stadler Inc.               510(k) NO: K172403(Traditional)
ATTN: Amy  Yanta                  PHONE NO : 952 9476097 
10395 West 70th Street            SE DECISION MADE: 20-OCT-17
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SenoBright HD
GE Healthcare                     510(k) NO: K172404(Traditional)
ATTN: Mounir  Zaouali             PHONE NO : 33 1 30709316 
283 rue de la Miniere             SE DECISION MADE: 30-OCT-17
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenuity TF
Philips Medical Systems (Cleveland510(k) NO: K172406(Traditional)
ATTN: Christine  Anderson         PHONE NO : 440 4837732 
595 Miner Rd                      SE DECISION MADE: 06-OCT-17
Cleveland OH  44143               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Bone Cement R
Biomet Inc                        510(k) NO: K172408(Traditional)
ATTN: Heidi  Busz                 PHONE NO : 574 3724249 
56 East Bell Drive                SE DECISION MADE: 05-OCT-17
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MT ONE
M&T S.R.L                         510(k) NO: K172413(Traditional)
ATTN: Fiorenzo  Rossi             PHONE NO : 39 054 1727486 
Via Pietrarubbia, 32/F            SE DECISION MADE: 06-OCT-17
Rimini  IT                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUD custom fit condom
Global Mailer Partners, LLC       510(k) NO: K172414(Abbreviated)
ATTN: Jud  Ireland                PHONE NO : 516 2797745 
50 South Pointe Drive             SE DECISION MADE: 12-OCT-17
Miami Beach FL  33139             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILC® Fixation System
Globus Medical Inc.               510(k) NO: K172417(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 2950
2560 General Armistead Ave.       SE DECISION MADE: 26-OCT-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Galaxy R Digital Radiography Upgrade
MEDIEN INTERNATIONAL CO LTD       510(k) NO: K172435(Traditional)
ATTN: Jae Hyun Lee                PHONE NO : 82 31 4519466 
Medien Office Tower, 50, Heungan-dSE DECISION MADE: 13-OCT-17
Anyang-Si  KR 435-040             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO Gelato Flavored Personal Lubricants
United Consortium                 510(k) NO: K172447(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 1 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 31-OCT-17
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
Thermo Fisher Scientific          510(k) NO: K172454(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322411
1 Thermo Fisher Way               SE DECISION MADE: 13-OCT-17
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
Volcano Corporation               510(k) NO: K172455(Special)
ATTN: Courtney  Moore             PHONE NO : 858 7641308 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 25-OCT-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coaxial Dilator Set (Micro-Introducer)
Galt Medical Corp.                510(k) NO: K172487(Traditional)
ATTN: David  Derrick              PHONE NO : 972 2715177 
2220 Merritt Dr.                  SE DECISION MADE: 16-OCT-17
Garland TX  75041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnsoETM
Attune Medical                    510(k) NO: K172493(Traditional)
ATTN: Erik  Kulstad               PHONE NO : 312 7254756 
3440 S. Dearborn St. #215-South   SE DECISION MADE: 17-OCT-17
Chicago IL  60616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
Microlife Intellectual Property Gm510(k) NO: K172498(Traditional)
ATTN: Gerhard  Frick              PHONE NO : 41 71 7277059 
Espenstrasse 139                  SE DECISION MADE: 13-OCT-17
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRE RX Biliary Balloon Dilatation Catheter
Boston Scientific Corporation     510(k) NO: K172520(Traditional)
ATTN: Jia  Huang                  PHONE NO : 508 6834360 
100 Boston Scientific Way         SE DECISION MADE: 04-OCT-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
Cook Incorporated                 510(k) NO: K172527(Traditional)
ATTN: Rebecca  Odulio (Li-chun LiuPHONE NO : 812 3353575 104673
750 Daniels Way. P.O. Box 489     SE DECISION MADE: 19-OCT-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINACwatch, LinacView
QualiFormeD Sarl                  510(k) NO: K172534(Traditional)
ATTN: Stephane  Beaumont          PHONE NO : 33 9 77009129 
14 Rue De La Vieille Horloge      SE DECISION MADE: 27-OCT-17
La Roche Sur Yon  FR 85000        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
Codman & Shurtleff, Inc.          510(k) NO: K172537(Traditional)
ATTN: Christopher  Garete         PHONE NO : 508 9773869 
325 Paramount Drive               SE DECISION MADE: 16-OCT-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
Liofilchem s. r. l.               510(k) NO: K172542(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia Zona ind.le            SE DECISION MADE: 23-OCT-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: AnyPlus® Spinal Fixation System
GS Medical Co., Ltd.              510(k) NO: K172546(Traditional)
ATTN: Marcin  Niemiec             PHONE NO : 
90, Osongsaengmyeong 4-ro         SE DECISION MADE: 23-OCT-17
Osong-eup, Cheongwon-gun  KR 363-9510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
Stryker Corporation               510(k) NO: K172558(Traditional)
ATTN: Kristi  Ashton              PHONE NO : 269 3895929 
4100 E. Milham Avenue             SE DECISION MADE: 05-OCT-17
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Upper-Face AXS screws and Mid-Face AXS screws
Stryker                           510(k) NO: K172572(Special)
ATTN: Jonathan  Schell            PHONE NO : 269 3895596 
750 Trade Centre Way - Suite 200  SE DECISION MADE: 31-OCT-17
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyncVision System
Volcano Corporation               510(k) NO: K172574(Traditional)
ATTN: Elaine  Alan                PHONE NO : 858 7641281 
3721 Valley Ctr. Dr.              SE DECISION MADE: 05-OCT-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liberty Anterior Cervical Plate
Valorus Spine                     510(k) NO: K172585(Traditional)
ATTN: Leah  Fero                  PHONE NO : 858 2459798 
696 San Ramon Valley Blvd.,Suite 4SE DECISION MADE: 23-OCT-17
Danville CA  94526                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Large Screws Range
Newclip Technics                  510(k) NO: K172596(Special)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 02-OCT-17
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
Alcon Laboratories, Inc.          510(k) NO: K172600(Traditional)
ATTN: Martina  Heim               PHONE NO : 678 4153565 
6201 South Freeway                SE DECISION MADE: 25-OCT-17
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
Philips Healthcare                510(k) NO: K172607(Third Party - Traditional)
ATTN: Maxs  Newberry              PHONE NO : 360 5812422 
22100 Bothell Everett Highway     SE DECISION MADE: 04-OCT-17
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
Surgical Instrument Service and Sa510(k) NO: K172608(Traditional)
ATTN: Stephanie Boyle Mays        PHONE NO : 541 9233310 
(dba Medline ReNewal) 1500 NE HemlSE DECISION MADE: 18-OCT-17
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Treace Medical Concepts (TMC) Compression Screw System
Treace Medical Concepts, Inc.     510(k) NO: K172617(Traditional)
ATTN: Rachel  Osbeck              PHONE NO : 904 3735940 304
3107 Sawgrass Village Circle      SE DECISION MADE: 25-OCT-17
Ponte Vedra Beach FL  32082       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
Hardy Diagnostics                 510(k) NO: K172621(Traditional)
ATTN: Andre  Hsiung               PHONE NO : 800 2662222 5706
1430 West McCoy Lane              SE DECISION MADE: 03-OCT-17
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
Medtronic, Inc.                   510(k) NO: K172626(Traditional)
ATTN: Lisa  Stone                 PHONE NO : 763 5149866 
8200 Coral Sea Street NE          SE DECISION MADE: 25-OCT-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XIDF-AWS801, Angio Workstation, V7.0
Toshiba Medical Systems Corporatio510(k) NO: K172646(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 30-OCT-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagVita TMS Therapy w/MagPro R20
Tonica Elektronik A/S             510(k) NO: K172667(Special)
ATTN: Lise  Terkelsen             PHONE NO : 45 44 998444 
Lucernemarken 15                  SE DECISION MADE: 05-OCT-17
Farum  DK 3520                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
Conmed Corporation                510(k) NO: K172671(Special)
ATTN: Lisa  Anderson              PHONE NO : 941 7132035 
525 French Road                   SE DECISION MADE: 04-OCT-17
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Applicator, 41 cm
Micromedics Inc. (d/b/a Nordson Me510(k) NO: K172672(Special)
ATTN: Kristi  Brezinka            PHONE NO : 651 4052183 
1270 Eagan Industrial Road, Suite SE DECISION MADE: 06-OCT-17
St.Paul MN  55121                 510(k) STATEMENT
                                                    

DEVICE: Edge Air Digital Flat Panel X-ray Detector
OSKO, INC.                        510(k) NO: K172681(Traditional)
ATTN: Richard  Jeon               PHONE NO : 305 5997161 
8085 NW 90 Street                 SE DECISION MADE: 06-OCT-17
Miami FL  33166                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Edge Digital Flat Panel X-ray Detector
Osko, Inc.                        510(k) NO: K172682(Traditional)
ATTN: Richard  Jeon               PHONE NO : 305 5997161 
8085 NW 90 Street                 SE DECISION MADE: 06-OCT-17
Miami FL  33166                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
Smith & Nephew, Inc.              510(k) NO: K172684(Special)
ATTN: Jonathan  DiMotta           PHONE NO : 901 3995471 
7135 Goodlett Farms Parkway       SE DECISION MADE: 03-OCT-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasonic Generator
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K172691(Special)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 04-OCT-17
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
Stryker Corporation               510(k) NO: K172724(Special)
ATTN: Priyanka  Patel             PHONE NO : 201 7498387 
2 Pearl Court                     SE DECISION MADE: 10-OCT-17
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Applanation tonometer AT-1
TAKAGI SEIKO CO., LTD.            510(k) NO: K172728(Traditional)
ATTN: Shinya  Kitamura            PHONE NO : 81 269 224511 
330-2                             SE DECISION MADE: 17-OCT-17
Nakano-shi  JP 383-8585           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
higi SH LLC                       510(k) NO: K172739(Traditional)
ATTN: Colin  Hill                 PHONE NO : 626 8645635 
800 Royal Oaks Dr. Suite 102 and 1SE DECISION MADE: 10-OCT-17
Monrovia CA  91016                510(k) STATEMENT
                                                    

DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
AtriCure, Inc.                    510(k) NO: K172742(Special)
ATTN: Melissa  Smallwood          PHONE NO : 513 6444736 
7555 Innovation Way               SE DECISION MADE: 11-OCT-17
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freemie Independence, Freemie Liberty
DAO Health                        510(k) NO: K172772(Third Party - Traditional)
ATTN: Dave  Paul                  PHONE NO : 916 3397388 
1345 Easy Lane                    SE DECISION MADE: 13-OCT-17
El Dorado Hills CA  95762         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DX-D Imaging Package
Agfa HealthCare N.V.              510(k) NO: K172784(Traditional)
ATTN: Wim  Govaerts               PHONE NO : 32 3 4446246 
Septestraat 27                    SE DECISION MADE: 13-OCT-17
Mortsel  BE B-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKR 3000
KONICA MINOLTA, INC.              510(k) NO: K172793(Special)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 12-OCT-17
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG SENTINEL System
Cardiomedix, Inc.                 510(k) NO: K172801(Third Party - Traditional)
ATTN: Zipora  David               PHONE NO : 847 8690230 
1840 Oak Ave.                     SE DECISION MADE: 18-OCT-17
Evanston IL  60201                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Infinitt PACS 7.0
Infinitt Healthcare Co.,Ltd.      510(k) NO: K172803(Traditional)
ATTN: Sang Wook Cho               PHONE NO : 82 2 21921631 
12FI Daerung Post Tower III, 27 DiSE DECISION MADE: 27-OCT-17
Seoul  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gi-4000 Electrosurgical Generator
United States Endoscopy Group, Inc510(k) NO: K172805(Special)
ATTN: Carroll L. Martin           PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 23-OCT-17
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: Bencox Mirabo Cup System
Corentec Co., Ltd                 510(k) NO: K172806(Special)
ATTN: J. S. Daniel                PHONE NO : 82 41 5857144 
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 17-OCT-17
Cheonan-si  KR 31056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CosmoLock Pedicle Screw System
Kalitec Direct, LLC               510(k) NO: K172808(Traditional)
ATTN: Scott  Winn                 PHONE NO : 407 5452063 
618 E. South Street, Suite 500    SE DECISION MADE: 25-OCT-17
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTC Combo TENS/EMS System
Well-Life Healthcare Limited      510(k) NO: K172809(Special)
ATTN: Chin-Chih  Hsieh            PHONE NO : 886 2 29282112 
1F, No.16, Lane 454, Jungjeng RoadSE DECISION MADE: 18-OCT-17
Yunghe Dist, New Taipei City  TW 2510(k) STATEMENT
                                                    

DEVICE: EsophyX Z, EsophyX2 HD
EndoGastric Solutions, Inc.       510(k) NO: K172811(Traditional)
ATTN: Steve  Hoffman              PHONE NO : 425 3079226 
18109 NE 76th Street Suite 100    SE DECISION MADE: 19-OCT-17
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
Shenzhen Beacon Display Technology510(k) NO: K172815(Traditional)
ATTN: Fu  Ailing                  PHONE NO : 86 075533 9851185150 
12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 27-OCT-17
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
Olympus Medical Systems Corp.     510(k) NO: K172817(Special)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 17-OCT-17
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Advanced Visualization, Version 7.6
Vital Images, Inc.                510(k) NO: K172855(Special)
ATTN: Katie  Ryan                 PHONE NO : 952 4879793 
5850 Opus Parkway Suite 300       SE DECISION MADE: 05-OCT-17
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery XR656 HD
GE Hualun Medical Systems Co.Ltd. 510(k) NO: K172869(Special)
ATTN: Kenny  Ma                   PHONE NO : 86 10 57388715 
No.1 YongChang North Road, BeijingSE DECISION MADE: 20-OCT-17
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroBlate System
Monteris Medical                  510(k) NO: K172881(Special)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North Suite C   SE DECISION MADE: 20-OCT-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arisure Closed Vial Adapter
Yukon Medical                     510(k) NO: K172884(Third Party - Traditional)
ATTN: Todd  Korogi                PHONE NO : 919 5958250 
4021 Stirrup Creek Dr. Suite #200 SE DECISION MADE: 03-OCT-17
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K172910(Traditional)
ATTN: Alan  Haley                 PHONE NO : 302 6319883 
P.O. Box 6101, M/S 514            SE DECISION MADE: 18-OCT-17
Newark DE  19714-6101             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Colorado Therapeutics Xenograft Implant
Colorado Therapeutics LLC         510(k) NO: K172937(Special)
ATTN: William  Jackson            PHONE NO : 303 4699459 
2150 West 6th Avenue, Suite L     SE DECISION MADE: 25-OCT-17
Bloomfield CA  80020              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANCHOR Tissue Retrieval System
Conmed Corporation                510(k) NO: K172940(Special)
ATTN: Rachelle D. Fitzgerald      PHONE NO : 203 7992400 8195
525 French Road                   SE DECISION MADE: 18-OCT-17
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex-Thread Fibula Pin System
IntraFuse LLC                     510(k) NO: K172943(Traditional)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West, Suite 100     SE DECISION MADE: 30-OCT-17
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
Varex Imaging Corporation         510(k) NO: K172951(Special)
ATTN: Catherine  Mulcahy          PHONE NO : 315 2346800 
121 Metropolitan Drive            SE DECISION MADE: 24-OCT-17
Liverpool NY  13088               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
ShenZhen Mindray Bio-Medical Elect510(k) NO: K172970(Traditional)
ATTN: Yang  Zhaohui               PHONE NO : 86 755 81885640 
Mindray Building, Keji 12th Road SSE DECISION MADE: 25-OCT-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPI K Console
Moria SA                          510(k) NO: K172994(Special)
ATTN: Jean-Paul  Mercereau        PHONE NO : 33 0 46744674 
15 Rue Georges Besse              SE DECISION MADE: 26-OCT-17
Antony  FR                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Ventura NanoMetalene System
SeaSpine Orthopedics Corporation  510(k) NO: K173022(Special)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 26-OCT-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip LAA Exclusion System with Preloaded PRO·V Clip
AtriCure, Inc.                    510(k) NO: K173031(Special)
ATTN: Melissa  Smallwood          PHONE NO : 513 6444736 
7555 Innovation Way               SE DECISION MADE: 25-OCT-17
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cocoon Portable Handheld X-Ray System
Dexcowin Co., Ltd.                510(k) NO: K173046(Special)
ATTN: Ryu  Seung-Bum              PHONE NO : 82 2 20272880 
#905, 2,, Gasan Digital 1-ro, GeumSE DECISION MADE: 26-OCT-17
Seoul  KR 08591                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heraeus TMW Guidewire
Heraeus Medical Components, LLC   510(k) NO: K173052(Traditional)
ATTN: Margaret  Batchelder        PHONE NO : 763 2256675 
2605 Fernbrook Lane North, Suite JSE DECISION MADE: 20-OCT-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
ACIST Medical Systems, Inc.       510(k) NO: K173063(Special)
ATTN: Amber R. Luker              PHONE NO : 952 9959300 
7905 Fuller Road                  SE DECISION MADE: 23-OCT-17
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
Huvexel Co., Ltd                  510(k) NO: K173080(Special)
ATTN: Sung  Hee-Lee               PHONE NO : 82 31 7763690 
101-105 Megacenter, SK Technopark,SE DECISION MADE: 31-OCT-17
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoVision
Ewoo Soft Co., Ltd.               510(k) NO: K173094(Special)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg. 13, SSE DECISION MADE: 26-OCT-17
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
Medos International SARL          510(k) NO: K173095(Special)
ATTN: Thao  Le                    PHONE NO : 508 9776308 
Chemin-Blanc 38                   SE DECISION MADE: 25-OCT-17
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Curve Image 2.0 PACS
Curve Dental LTD                  510(k) NO: K173101(Special)
ATTN: Raul  Nemes                 PHONE NO : 1 403 2454088 1004
Suite 240, 2912 Memorial Dr. SE   SE DECISION MADE: 18-OCT-17
Calgary  CA T2A6R1                510(k) STATEMENT
                                                    

DEVICE: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
Total Joint Orthopedics, Inc.     510(k) NO: K173104(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 27-OCT-17
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Abbott Architect Free T4
Abbott Laboratories               510(k) NO: K173122(Special)
ATTN: Linda  Sohn                 PHONE NO : 224 6674846 
100 Abbott Park Road Dept. 09AA, BSE DECISION MADE: 27-OCT-17
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASPIRE Cristalle
Fujifilm Medical Systems U.S.A., I510(k) NO: K173132(Special)
ATTN: Jyh-Shyan  Lin              PHONE NO : 301 2511092 
419 West Avenue                   SE DECISION MADE: 27-OCT-17
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biim Diagnostic Ultrasound System
Biim Ultrasound AS                510(k) NO: K173138(Third Party - Traditional)
ATTN: Rune  Nystad                PHONE NO : 47 91 624683 
Frydenlundsgt 9                   SE DECISION MADE: 27-OCT-17
Narvik  NO 8516                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Boston Scientific                 510(k) NO: K173184(Special)
ATTN: Jennifer  Edouard           PHONE NO : 508 6836134 
100 Boston Scientific Way         SE DECISION MADE: 27-OCT-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
Aziyo Biologics, Inc.             510(k) NO: K173242(Special)
ATTN: Wendy  Perreault            PHONE NO : 
1100 Old Ellis Road, Suite 1200   SE DECISION MADE: 25-OCT-17
Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid HB, Rapid LB, Rapid MB
3M Deutschland GmbH               510(k) NO: K173318(Third Party - Traditional)
ATTN: Ruediger  Franke            PHONE NO : 49 8152 7001802 
ESPE Platz                        SE DECISION MADE: 31-OCT-17
Seefeld  DE 82229                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


               TOTAL 510(k)s THIS PERIOD   284                                     
               TOTAL WITH SUMMARIES        266                                     
               TOTAL WITH STATEMENTS        18