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  1. 510(k) Clearances

December 2019 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2019


DEVICE: Pantheon Spinal Pontus Interbody Fusion Device
Pantheon Spinal                   510(k) NO: K181548(Traditional)
ATTN: Bob  Schultz                PHONE NO : 512 2154888 
3008 Bee Cave Road, Suite 200     SE DECISION MADE: 16-DEC-19
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental high speed handpiece, Dental low speed handpiece
Foshan CICADA Dental Instrument Co510(k) NO: K181900(Traditional)
ATTN: Juan  Liu                   PHONE NO : 86 757 85775667 
B5-2F, Guangdong New Light Source SE DECISION MADE: 09-DEC-19
Foshan  CN 528247                 510(k) STATEMENT
                                                    

DEVICE: Krystal Klear Aligners
Shatkin F.I.R.S.T. LLC            510(k) NO: K182388(Traditional)
ATTN: Kimberly  Wiesmore          PHONE NO : 716 8392959 
2495 Kensington Avenue            SE DECISION MADE: 19-DEC-19
Amherst NY  14226                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
Fengh Medical Co., Ltd.           510(k) NO: K182476(Traditional)
ATTN: Jiao  Liu                   PHONE NO : 0086 138 15132106 
D3 No.6 Dongsheng West Road, JiangSE DECISION MADE: 18-DEC-19
Jiangyin  CN 214437               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini and Micro Fragments Reconstruction System – GMReis
Gm Dos Reis Industria E Comerico L510(k) NO: K182718(Traditional)
ATTN: Paula  Oliveira             PHONE NO : 55 19 37659900 
Avenida Pierre Simon De La Place 6SE DECISION MADE: 23-DEC-19
Campinas  BR 13069320             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corelink Navigation Instruments
Corelink LLC                      510(k) NO: K182731(Traditional)
ATTN: Steven D. Mounts            PHONE NO : 1 888 3497808 
7911 Forsyth Blvd, Suite #200     SE DECISION MADE: 13-DEC-19
St. Louis MO  63105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endotracheal Tube with Evacuation Lumen
WELL LEAD MEDICAL CO., LTD.       510(k) NO: K182739(Special)
ATTN: Huang  Kaigen               PHONE NO : 86 20 84758878 
C-4 # Jinhu Industrial Estate, HuaSE DECISION MADE: 11-DEC-19
Guangzhou  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MCI - CMF System
MCI Medical Concept Innovation Inc510(k) NO: K182758(Traditional)
ATTN: Carlos  Lacerda             PHONE NO : 01 954 3062521 
4592 North Hiatus Road            SE DECISION MADE: 05-DEC-19
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Decanting Device
Gcmedica Enterprise Ltd., (WUXI)  510(k) NO: K182819(Traditional)
ATTN: Mona  Zhang                 PHONE NO : 0086 510 85300900 
Loujin Industrial Park, Shuofang  SE DECISION MADE: 02-DEC-19
Wuxi  CN 214143                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine 3DP Lumbar Interbody System
Genesys Spine                     510(k) NO: K182987(Traditional)
ATTN: William W. Sowers           PHONE NO : 512 3817080 
1250 South Capital of Texas HighwaSE DECISION MADE: 12-DEC-19
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ID-Cap System
etectRx, Inc.                     510(k) NO: K183052(Traditional)
ATTN: Susan  Baumgartner          PHONE NO : 352 4435713 101
747 SW 2nd Ave Suite 365T, IMB 24 SE DECISION MADE: 06-DEC-19
Gainesville FL  32601             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMC 560i
Shanghai United Imaging Healthcare510(k) NO: K183144(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 21 67076888 6776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 19-DEC-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IceSense 3, ProSense, MultiSense
IceCure Medical LTD.              510(k) NO: K183213(Traditional)
ATTN: Elisabeth  Sadka            PHONE NO : 972 52 5670666 
7 Haeshel St., P.O. Box 3163      SE DECISION MADE: 20-DEC-19
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deka Tiac 1
El..En. Electroic Engineering SpA 510(k) NO: K183371(Traditional)
ATTN: Paolo  Peruzzi              PHONE NO : 39 055 8826807 
via Baldanzese 17                 SE DECISION MADE: 03-DEC-19
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambar, Ambar APS, Ambar Universal APS
DentsCare LTDA                    510(k) NO: K183424(Traditional)
ATTN: Roberta  Uyara              PHONE NO : 55 47 34416131 
Av. Edgar Nilson Meister, 474     SE DECISION MADE: 13-DEC-19
Joinville  BR 89219-501           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NasalCEASE and BleedCEASE
Les Laboratoires Brothier S.A.    510(k) NO: K183622(Traditional)
ATTN: Christian  Girardiere       PHONE NO : 33 01 56383000 
41 rue de Neuilly                 SE DECISION MADE: 02-DEC-19
Nanterre  FR 92735                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DentiqAir
3D Industrial Imaging Co., Ltd.   510(k) NO: K183676(Traditional)
ATTN: Bora  Choi                  PHONE NO : 82 70 87669192 
Bldg.138, Rm.413, Seoul National USE DECISION MADE: 19-DEC-19
Seoul  KR 0882                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carescape One
GE Healthcare                     510(k) NO: K190008(Traditional)
ATTN: Joel  Kent                  PHONE NO : 617 8510943 
8200 West Tower Avenue            SE DECISION MADE: 20-DEC-19
Milwaukee WI  53223               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K190009(Traditional)
ATTN: Xu  Jianhua                 PHONE NO : 86 755 26423615 
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 02-DEC-19
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
Medtrade Product Ltd              510(k) NO: K190012(Traditional)
ATTN: Mina  Patel                 PHONE NO : 44 01270 500019 276
Electra House, Electra way, Crewe SE DECISION MADE: 18-DEC-19
Crewe  GB CW1 6GL                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile Zirconia Block
Fine Advanced Compound Co., Ltd   510(k) NO: K190112(Traditional)
ATTN: Jeong  Kwang-Ho             PHONE NO : 82 31 3589312 
7, Galgot-gil, Jinwi-myeon        SE DECISION MADE: 20-DEC-19
Pyeongtaek  KR                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Aspiration Needle
Olympus Medical Systems Corp.     510(k) NO: K190239(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 10-DEC-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Latex Surgical Glove, Powder Free
Careglove Global Sdn Bhd          510(k) NO: K190241(Traditional)
ATTN: Lim Kwee Shyan              PHONE NO : 60 6 6782377 
Lot 17479, Lrg Senawang 3/2, Off JSE DECISION MADE: 30-DEC-19
Seremban  MY 70450                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T3 Platform software
Etiometry, Inc.                   510(k) NO: K190273(Traditional)
ATTN: Tim  Hanson                 PHONE NO : 857 3669333 
280 Summer St. 4th Floor          SE DECISION MADE: 08-DEC-19
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bengal Stackable Cage System
Medos International SARL          510(k) NO: K190284(Traditional)
ATTN: Linda  Bernier              PHONE NO : 508 8282837 
Chemin-Blanc 38                   SE DECISION MADE: 20-DEC-19
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intraocular Pressure Tonometer EASYTON
Company Elamed                    510(k) NO: K190382(Traditional)
ATTN: Mikhail  Kuzin              PHONE NO : 74 912 777598 
Yelatma instrument-making enterpriSE DECISION MADE: 06-DEC-19
Yelatma  RU                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SunClear Aligner system
Sun Dental Laboratories, LLC      510(k) NO: K190394(Traditional)
ATTN: Derek  Diasti               PHONE NO : 727 5619777 
1800 9th Ave N                    SE DECISION MADE: 16-DEC-19
St. Petersburg FL  33713          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHelmet Hair Growth System
Slinph Technologies Co., LTD      510(k) NO: K190467(Traditional)
ATTN: Zou  Jian                   PHONE NO : 86 158 15568501 
Room 211, Building B, 1970 CulturaSE DECISION MADE: 26-DEC-19
Shenzhen  CN 518107               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVO 450 series High Speed Handpieces
TTBIO CORP.                       510(k) NO: K190508(Traditional)
ATTN: Sheng-Chieh  Su             PHONE NO : 886 4 23595958 
2F, No.7, 6th Road Industry Park  SE DECISION MADE: 11-DEC-19
Taichung  TW 40755                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIO-C Sealer Ion+
Angelus Industria de Produtos Odon510(k) NO: K190537(Abbreviated)
ATTN: Paulo Sergio Calixto De OlivPHONE NO : 55 43 21013205 
Rua Waldir Landgraf, 101          SE DECISION MADE: 12-DEC-19
Londrina  BR 86.031-218           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JJ Implant System
JJ Implants                       510(k) NO: K190552(Traditional)
ATTN: Jiju  John                  PHONE NO : 91 984 6008283 
IX /214A, Munipara, Kanjirapilly PSE DECISION MADE: 06-DEC-19
Chalakudy  IN 680721              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation  510(k) NO: K190588(Traditional)
ATTN: Blesson  Abraham            PHONE NO : 512 8523942 
11101 Metric Blvd                 SE DECISION MADE: 02-DEC-19
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EQUINOX Balloon Dilatation Catheter
Dornier MedTech America Inc       510(k) NO: K190612(Traditional)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts Blvd, Suite 100      SE DECISION MADE: 06-DEC-19
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NanoOrtho NanoKnee® System
NanoOrtho, LLC                    510(k) NO: K190633(Traditional)
ATTN: Austin  Ferro               PHONE NO : 805 7148984 
860 Oak Park Blvd STE 301         SE DECISION MADE: 20-DEC-19
Arroyo Grande CA  93420           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Zimmer Inc.                       510(k) NO: K190656(Traditional)
ATTN: Charles  Neitzel            PHONE NO : 262 7163243 
P.O. Box 708                      SE DECISION MADE: 06-DEC-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
Allwin Medical Devices, Inc.      510(k) NO: K190659(Traditional)
ATTN: Digish  Mehta               PHONE NO : 714 5721709 
3305 E. Mira Loma Avenue, Suite 17SE DECISION MADE: 02-DEC-19
Anaheim CA  92806                 510(k) STATEMENT
                                                    

DEVICE: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
Zimmer, Inc.                      510(k) NO: K190660(Traditional)
ATTN: Mary  Wentorf               PHONE NO : 574 5279517 
P.O. Box 708                      SE DECISION MADE: 05-DEC-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Instrument Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K190665(Traditional)
ATTN: Luiza Vaccari Toppel        PHONE NO : 55 41 21694150 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 23-DEC-19
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Health Expert Electronic Stimulator
Shenzhen OSTO Technology Company L510(k) NO: K190673(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 12-DEC-19
Longgang District, Shenzhen City  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
Interscope, Inc.                  510(k) NO: K190715(Traditional)
ATTN: Jeffery  Ryan               PHONE NO : 877 4207299 
100 Main Street, Suite 108        SE DECISION MADE: 13-DEC-19
Whitinsville MA  01588            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer, model: PC808
Shenzhen Pacom Medical Instruments510(k) NO: K190717(Traditional)
ATTN: Xuewen  Chen                PHONE NO : 86 755 32920339 
8th floor of B District, B BuildinSE DECISION MADE: 13-DEC-19
Shenzhen  CN 518105               510(k) STATEMENT
                                                    

DEVICE: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Riverstone Resources SDN BHD      510(k) NO: K190725(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 603 60283033 
Lot 56, No 15, Jalan Jasmin 2     SE DECISION MADE: 17-DEC-19
Bukit Beruntung  MY 48300         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IODOSORB
Smith & Nephew Medical Ltd.       510(k) NO: K190730(Traditional)
ATTN: Meenakshi  Gupta            PHONE NO : 901 3996139 
101 Hessle Road                   SE DECISION MADE: 20-DEC-19
Hull East Riding of Yorkshire  GB 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
Ever Growth (Vietnam) Co. Ltd.    510(k) NO: K190736(Abbreviated)
ATTN: Ming  Lee                   PHONE NO : 84 61 3514025 
Long Khanh Industrial Zone BinhlocSE DECISION MADE: 23-DEC-19
Binhloc Village  VN 810000        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyShoulder Placement Guides
Medacta International SA          510(k) NO: K190738(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 13-DEC-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIFLO-28
Neogenix, LLC dba Ogenix          510(k) NO: K190742(Traditional)
ATTN: Srinivasan  Sarangapani     PHONE NO : 781 7026732 
3401 Enterprise Pkwy, Suite 340   SE DECISION MADE: 13-DEC-19
Beachwood OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Satisfaite
FemmePharma Consumer Healthcare, L510(k) NO: K190752(Traditional)
ATTN: Gerianne  DiPiano           PHONE NO : 610 9950801 18
175 Strafford Ave., Bldg 4, Suite SE DECISION MADE: 13-DEC-19
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IODOFLEX
Smith & Nephew Medical Ltd.       510(k) NO: K190756(Traditional)
ATTN: Meenakshi  Gupta            PHONE NO : 901 3996139 
10 I Hessle Road                  SE DECISION MADE: 20-DEC-19
Hull East Riding Of Yorkshire  GB 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The RHEA Vital Sign Vigilance System
Shenzhen Fiber Medical Technology 510(k) NO: K190775(Traditional)
ATTN: Luo  Li                     PHONE NO : 86 1857 76650186 
Room 501, Sun Mate Science and TecSE DECISION MADE: 19-DEC-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tablo Hemodialysis System, Tablo Cartridge
Outset Medical, Inc.              510(k) NO: K190793(Traditional)
ATTN: Jennifer  Mascioli-Tudor    PHONE NO : 669 2318200 
1830 Bering Drive                 SE DECISION MADE: 12-DEC-19
San Jose CA  95112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
PENTAX of America, Inc.           510(k) NO: K190805(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 20-DEC-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
Bluepoint Medical GmbH & Co. KG   510(k) NO: K190824(Traditional)
ATTN: Bernd  Lindner              PHONE NO : 49 38823 5488000 
An der Trave 15                   SE DECISION MADE: 18-DEC-19
Selmsdorf  DE 23923               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
Wilson-Cook Medical, Inc. / Cook E510(k) NO: K190829(Traditional)
ATTN: Tiffanny A Thomas           PHONE NO : 336 7440157 396680
4900 Bethania Station Road        SE DECISION MADE: 19-DEC-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Vecta Aspiration Catheter
Stryker Neurovascular             510(k) NO: K190833(Traditional)
ATTN: Shazia  Hakim               PHONE NO : 510 4132636 
47900 Bayside Parkway             SE DECISION MADE: 15-DEC-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
Ever Growth (Vietnam) Co. Ltd.    510(k) NO: K190860(Abbreviated)
ATTN: Ming  Lee                   PHONE NO : 84 61 3514025 
Long Khanh Industrial Zone BinhlocSE DECISION MADE: 23-DEC-19
Binhloc Village  VN 810000        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Mercator Medical (Thailand) LTD.  510(k) NO: K190876(Traditional)
ATTN: Dariusz Jan Krezymon        PHONE NO : 66 74 584222 
88/8, 88/9 Moo 12 Tambon KampaengpSE DECISION MADE: 02-DEC-19
Amphur Rattaphum  TH 90180        510(k) STATEMENT
                                                    

DEVICE: Spinal Elements Navigated Instruments
Spinal Elements Inc               510(k) NO: K190881(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071840 
3115 Melrose Dr. Suite 200        SE DECISION MADE: 19-DEC-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
Datascope Corp.                   510(k) NO: K190884(Traditional)
ATTN: Mark  Dinger                PHONE NO : 973 7097691 
15 Law Drive                      SE DECISION MADE: 26-DEC-19
Fairfield NJ  07004               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lawson Retrograde Nephrostomy Wire Puncture Set
Cook Incorporated                 510(k) NO: K190903(Traditional)
ATTN: Andrew  Breidenbach         PHONE NO : 812 3353575 105147
750 Daniels Way                   SE DECISION MADE: 16-DEC-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: xvision Spine system (XVS)
Augmedics Ltd.                    510(k) NO: K190929(Traditional)
ATTN: Tami  Harel                 PHONE NO : 972 4 3730111 
1 Ha-Tsmikha St                   SE DECISION MADE: 20-DEC-19
Yokneam lllit  IL 2069205         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZER, Portable X-ray System
Livermoretech Inc.                510(k) NO: K190935(Traditional)
ATTN: Jae Hong Kim                PHONE NO : 1 214 2570113 
801 North Jupiter Rd, Suite 200   SE DECISION MADE: 19-DEC-19
Plano TX  75074                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZOLL Arrhythmia Management Sysyem
ZOLL Manufacturing Corporation    510(k) NO: K190939(Traditional)
ATTN: Zachary  Nelson             PHONE NO : 412 9683333 14814
121 Gamma Drive                   SE DECISION MADE: 19-DEC-19
Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEDIA Benzodiazepine Assay
Microgenics Corporation           510(k) NO: K190968(Traditional)
ATTN: Minoti  Patel               PHONE NO : 510 9795000 
45600 Kato Road                   SE DECISION MADE: 09-DEC-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uroject12 Syringe Lever
UroGen Pharma Ltd.                510(k) NO: K190987(Special)
ATTN: Liz  Schindel               PHONE NO : 972 9 7707600 
9 Ha`Ta`asiya Street              SE DECISION MADE: 02-DEC-19
Ra’anana  IL 4365405              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
Xiamen Ants Bro Technology Co., Lt510(k) NO: K190990(Traditional)
ATTN: Jane  Xu                    PHONE NO : 86 592 6537633 
4th & 5th Floor, No.5 Building, TeSE DECISION MADE: 31-DEC-19
Xiamen  CN 361026                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Southern Implants MAX Implant System
Southern Implants (Pty) Ltd       510(k) NO: K191054(Traditional)
ATTN: Lauranda G. Breytenbach     PHONE NO : 27 12 6671046 
1 Albert Road                     SE DECISION MADE: 09-DEC-19
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Rad-97 and Accessories
Masimo Corporation                510(k) NO: K191059(Traditional)
ATTN: Linus  Park                 PHONE NO : 949 2977000 
52 Discovery                      SE DECISION MADE: 27-DEC-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exciplex
Clarteis                          510(k) NO: K191086(Traditional)
ATTN: Laurent  Meilhac            PHONE NO : 33 954 039377 
WTC2, 120 route des macarons      SE DECISION MADE: 11-DEC-19
Valbonne  FR 06560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntraMarX Radiopaque Markers
AnX Robotica Corp.                510(k) NO: K191087(Traditional)
ATTN: Lin  Wang                   PHONE NO : 510 4492263 
7213 Regency Court                SE DECISION MADE: 18-DEC-19
Plano TX  75204                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Checkme O2 Pulse Oximeter
Shenzhen Viatom Technology Co., Lt510(k) NO: K191088(Traditional)
ATTN: Zhou  Saixin                PHONE NO : 86 755 86638929 
4E, Building 3, Tinwei Industrial SE DECISION MADE: 02-DEC-19
Baoan District Guandong  CN 518101510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C50 and C80 Multi-parameter Patient Monitor
Shenzhen Comen Medical Instruments510(k) NO: K191106(Traditional)
ATTN: Hongbo  Yan                 PHONE NO : 86 1342 4152596 
Floor 11 and Section C of Floor 12SE DECISION MADE: 13-DEC-19
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avanti Distal Radius and Forearm System
Avanti Orthopaedics, Inc.         510(k) NO: K191118(Traditional)
ATTN: J. Doug Patterson           PHONE NO : 302 5306369 
4606 Simon Road                   SE DECISION MADE: 13-DEC-19
Wilmington DE  19803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumax Guiding Catheter
Cook Incorporated                 510(k) NO: K191163(Traditional)
ATTN: David  Lehr                 PHONE NO : 812 3392235 102309
750 Daniels Way                   SE DECISION MADE: 12-DEC-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System - Temporary Abutments
JJGC Industria e Comercio de Mater510(k) NO: K191191(Traditional)
ATTN: Mariana Soares Hartmann     PHONE NO : 55 41 21694058 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 05-DEC-19
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
Erbe Elektromedizin GmbH          510(k) NO: K191234(Traditional)
ATTN: Henry  Kutz                 PHONE NO : 0049 7071 7550 
Waldhoernlestrasse 17             SE DECISION MADE: 20-DEC-19
Tuebingen  DE 72072               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Peak Flow Meter
Guangzhou Homesun Medical Technolo510(k) NO: K191239(Traditional)
ATTN: Jinqun  Li                  PHONE NO : 86 020 34003801 
Floor 7th, TianxiangBusiness BuildSE DECISION MADE: 06-DEC-19
Guangzhou  CN 510250              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Southern Implants PEEK Abutments
Southern Implants (Pty) Ltd       510(k) NO: K191250(Traditional)
ATTN: Lauranda  Breytenbach       PHONE NO : 27 12 6671046 
1 Albert Road                     SE DECISION MADE: 05-DEC-19
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann BLX Ø3.5 mm Implants
Institut Straumann AG             510(k) NO: K191256(Traditional)
ATTN: Ana C. M. Vianna            PHONE NO : 41 61 9651512 
Peter Merian Weg 12               SE DECISION MADE: 27-DEC-19
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable SpO2 Sensor
Shenzhen Caremed Medical Technolog510(k) NO: K191279(Traditional)
ATTN: Alan  Xie                   PHONE NO : 86 755365 60977889 
East Side, 3/F, C Building, KeluntSE DECISION MADE: 06-DEC-19
Dalang Office, Longhua District, S510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hereaeus Poseidon Microcatheter
Heraeus Medical Components, LLC   510(k) NO: K191305(Traditional)
ATTN: Chelsea  Pioske             PHONE NO : 763 2256500 
2605 Fernbrook Lane North, Suite JSE DECISION MADE: 19-DEC-19
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Llis, Vittra APS
Dentscare LTDA                    510(k) NO: K191306(Traditional)
ATTN: Roberta  Uyara              PHONE NO : 55 47 34416131 
Av. Edgar Nelson Meister, 474     SE DECISION MADE: 16-DEC-19
Joinville  BR 89219-501           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
Chongqing Sunkingdom Medical Instr510(k) NO: K191314(Traditional)
ATTN: Shulin  Guo                 PHONE NO : 
1012, Block A of China Resource CeSE DECISION MADE: 19-DEC-19
Chongqing  CN 400050              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACTIVE® Free Testosterone RIA
Immunotech s.r.o.                 510(k) NO: K191350(Special)
ATTN: Vit  Oburka                 PHONE NO : 420 272 017368 
Radiova 1                         SE DECISION MADE: 20-DEC-19
Prague  CZ 10227                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MolecuLight i:X
MolecuLight Inc.                  510(k) NO: K191371(Traditional)
ATTN: Anil  Amlani                PHONE NO : 416 5425530 
Suite 700, 425 University Avenue  SE DECISION MADE: 04-DEC-19
Toronto  CA M5G 1T6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RELiZORB
Alcresta Therapeutics, Inc.       510(k) NO: K191379(Traditional)
ATTN: Eric  First                 PHONE NO : 617 4313600 
One Newton Executive Park, Suite 1SE DECISION MADE: 04-DEC-19
Newton MA  02462                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Nonin Medical, Inc.               510(k) NO: K191403(Traditional)
ATTN: Walter  Holbein             PHONE NO : 763 5775504 
13700 1st Avenue North            SE DECISION MADE: 20-DEC-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragonix SherpaPak Pancreas Transport System
Paragonix Technologies            510(k) NO: K191440(Traditional)
ATTN: Lisa M. Anderson            PHONE NO : 1 781 4284828 
Suite 408, 639 Granite St.        SE DECISION MADE: 20-DEC-19
Braintree MA  02184               510(k) STATEMENT
                                                    

DEVICE: Straumann Modular Cassette
Institut Straumann AG             510(k) NO: K191522(Traditional)
ATTN: Jenni  Vescovo              PHONE NO : 41 61 9651292 
Peter Merian-Weg 12               SE DECISION MADE: 03-DEC-19
Basel  CH 4002                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RIST Cath Radial Access Long Sheath
RIST Neurovascular, Inc.          510(k) NO: K191551(Traditional)
ATTN: Marianne  Grumwaldt         PHONE NO : 305 4953883 
11611 Interchange Circle S        SE DECISION MADE: 23-DEC-19
Miramar FL  33025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioSticker System
BioIntelliSense Inc.              510(k) NO: K191614(Traditional)
ATTN: Henry  Leung                PHONE NO : 408 6556027 
570 El Camino Real, Suite 200     SE DECISION MADE: 18-DEC-19
Redwood City CA  94063            510(k) STATEMENT
                                                    

DEVICE: SleepTight Mouthpiece STZ
Michael D Williams DDS PA         510(k) NO: K191618(Traditional)
ATTN: Michael  Williams           PHONE NO : 954 4759154 
10991 SW 42ND PL                  SE DECISION MADE: 11-DEC-19
Davie FL  33328                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TK Sterile Hypodermic Needle
Anhui Tiankang Medical Technology 510(k) NO: K191643(Traditional)
ATTN: Bai  Baodong                PHONE NO : 86 550 7309187 
NO.228 Weiyi Road, Economic DeveloSE DECISION MADE: 19-DEC-19
Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QLAB Advanced Quantification Software
Philips Healthcare                510(k) NO: K191647(Traditional)
ATTN: Eri  Gremi                  PHONE NO : 978 6592980 
22100 Bothell Everett Highway     SE DECISION MADE: 20-DEC-19
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zipbond
SDI Limited                       510(k) NO: K191656(Traditional)
ATTN: Ray  Cahill                 PHONE NO : 61 3 87277111 
3-15 Brunsdon Street              SE DECISION MADE: 02-DEC-19
Bayswater  AU 3153                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unscented W long plastic and cardboard applicator tampons
ONTEX BVBA                        510(k) NO: K191666(Traditional)
ATTN: Henri  Lesage               PHONE NO : 32 52 454611 
5 Genthof                         SE DECISION MADE: 20-DEC-19
Buggenhout Oost - Vlaanderen  BE 9510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Stethoscope
Hefei Mintti Medical Technology Co510(k) NO: K191667(Traditional)
ATTN: Shengsheng  Cai             PHONE NO : 86 0551 63638810 
C309, National University Science SE DECISION MADE: 18-DEC-19
Hefei  CN 230088                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Cook Biotech Incorporated         510(k) NO: K191696(Traditional)
ATTN: Perry W. Guinn              PHONE NO : 765 4973355 
1425 Innovation Place             SE DECISION MADE: 27-DEC-19
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EyeStat
Blinktbi Inc.                     510(k) NO: K191700(Traditional)
ATTN: Ryan  Fiorini               PHONE NO : 843 5078995 
635 Rutledge Ave., Suite 102      SE DECISION MADE: 09-DEC-19
Charleston SC  29403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Navigation System
Zimmer Biomet Spine, Inc.         510(k) NO: K191722(Traditional)
ATTN: Alex  Pawlowski             PHONE NO : 303 5331062 
10225 Westminster Drive           SE DECISION MADE: 02-DEC-19
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EM Provisional
Hiossen, Inc.                     510(k) NO: K191751(Abbreviated)
ATTN: Peter  Lee                  PHONE NO : 888 6780001 
85 Ben Fairless Drive             SE DECISION MADE: 16-DEC-19
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
Argon Medical Devices, Inc.       510(k) NO: K191758(Traditional)
ATTN: Jo  Huang                   PHONE NO : 903 6779237 
1445 Flat Creek Road              SE DECISION MADE: 17-DEC-19
Athens TX  75751                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Quick Switch Valve with ENFit Connector
Medline Industries, Inc.          510(k) NO: K191759(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9792687 
Three Lakes Drive                 SE DECISION MADE: 04-DEC-19
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO 14 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K191760(Traditional)
ATTN: Sam  Greenhalgh             PHONE NO : 44 1482 673436 
101 Hessle Road                   SE DECISION MADE: 05-DEC-19
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
Nebula Surgical Private Limited   510(k) NO: K191793(Traditional)
ATTN: Rajat Kumar Khant           PHONE NO : 91 281 2584832 
Nebula, Narmada Park-3,Amin Marg, SE DECISION MADE: 09-DEC-19
Rajkot  IN 360005                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neo Cage System
Neo Medical S.A.                  510(k) NO: K191796(Traditional)
ATTN: Jonas  Larsson              PHONE NO : 41 22 5483880 
Route de Lausanne 157A            SE DECISION MADE: 13-DEC-19
Villette (Lavaux)  CH 1096        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOMi Scope
PhotoniCare, Inc.                 510(k) NO: K191804(Traditional)
ATTN: Ryan  Shelton               PHONE NO : 405 8807209 
60 Hazelwood Dr.                  SE DECISION MADE: 05-DEC-19
Champaign IL  61820               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear-Aligners
CDB Corporation                   510(k) NO: K191823(Traditional)
ATTN: Leah M. Lehman              PHONE NO : 910 3836464 
9201 Industrial Blvd              SE DECISION MADE: 20-DEC-19
Leland NC  28451                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stand-Alone ALIF Titanium System
Life Spine Inc.                   510(k) NO: K191834(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 16-DEC-19
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceramill A-Splint
Amann Girrbach AG                 510(k) NO: K191836(Traditional)
ATTN: Debora  Engel               PHONE NO : 49 7231 957260 
Herrschaftswiesen 1               SE DECISION MADE: 20-DEC-19
Koblach  AT 6842                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAXReach Laser Probe
Vortex Surgical Inc.              510(k) NO: K191846(Traditional)
ATTN: Bob  Neu                    PHONE NO : 636 7784350 
680 Crown Industrial Ct. Suite F  SE DECISION MADE: 23-DEC-19
Chesterfield MO  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aurora Surgiscope System
Rebound Therapeutics              510(k) NO: K191861(Traditional)
ATTN: Naomi  Gong                 PHONE NO : 949 3048111 
13900 Alton Parkway Suite 120     SE DECISION MADE: 06-DEC-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 21HK512D
LG Electronics Inc.               510(k) NO: K191864(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
222, LG-ro, Cheongho-ri, Jinwi-myeSE DECISION MADE: 05-DEC-19
Pyeongtaek-si  KR 17709           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRX-Evolution with Carestream Digital Tomosynthesis
Carestream Health, Inc.           510(k) NO: K191879(Traditional)
ATTN: Duane  Gutowski             PHONE NO : 585 6278760 
150 Verona Street                 SE DECISION MADE: 20-DEC-19
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K191880(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 11-DEC-19
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Mini Implants
Institut Straumann AG             510(k) NO: K191895(Traditional)
ATTN: Viviana  Horhoiu            PHONE NO : 41 61 9651512 
Peter Merian Weg 12               SE DECISION MADE: 09-DEC-19
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Latex Powder-Free Surgical Gloves
Modern Healthcare Corp.           510(k) NO: K191898(Traditional)
ATTN: Ke-Min  Jen                 PHONE NO : 886 4 8752116 
No. 751, Chung Chou Road, Sec. 2, SE DECISION MADE: 18-DEC-19
Chang-Hwa  TW 520456              510(k) STATEMENT
                                                    

DEVICE: Arthrex Univers Revers Modular Glenoid System
Arthrex Inc.                      510(k) NO: K191960(Special)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 23-DEC-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitra 2
Quantel Medical                   510(k) NO: K191962(Traditional)
ATTN: Bruno  Pages                PHONE NO : 33 473 745732 
11 Rue du Bois Joli-CS40015       SE DECISION MADE: 05-DEC-19
Cournon D'Auvergne-Cedex  FR 63808510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unyvero LRT BAL Application
Curetis GmbH                      510(k) NO: K191967(Traditional)
ATTN: Karsten  Mueller            PHONE NO : 49 7031 4919510 
Max-Eyth-Straße 42                SE DECISION MADE: 20-DEC-19
Holzgerlingen  DE 71088           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BC Reflex Uni Knee System
Bodycad Laboratories, Inc.        510(k) NO: K191996(Traditional)
ATTN: Guy  Sevigny                PHONE NO : 418 5271388 
2035, rue du Haut-Bord            SE DECISION MADE: 05-DEC-19
Quebec City  CA g1n 4r7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Blood Pressure Monitor
Truly Instrument Limited          510(k) NO: K192023(Abbreviated)
ATTN: Su  HaiSen                  PHONE NO : 86 0660 3363561 
Site 2, Truly Industry Area       SE DECISION MADE: 23-DEC-19
ShanWei  CN 516600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WEREWOLF COBLATION System, COBLATION HALO Wand
Arthrocare Corporation            510(k) NO: K192027(Traditional)
ATTN: Shruthi  Bhat               PHONE NO : 512 8951295 
7000 West William Cannon Drive    SE DECISION MADE: 20-DEC-19
Austin TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Emprint Visualization Application
Covidien LLC.                     510(k) NO: K192038(Traditional)
ATTN: Janna  Babson               PHONE NO : 303 8768721 
5920 Longbow Drive                SE DECISION MADE: 02-DEC-19
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVIEW Modeler
Coreline Soft Co., Ltd            510(k) NO: K192040(Traditional)
ATTN: Hyeyi  Park                 PHONE NO : 82 2 5717321 
4, 5F (Yeonnam-dong), 49, World CuSE DECISION MADE: 20-DEC-19
Seoul  KR 03991                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4CIS Marlin PEEK ACIF Cage
Solco Biomedical Co., Ltd.        510(k) NO: K192044(Traditional)
ATTN: Hwi-geun  Yu                PHONE NO : 82 31 6644101 
154 Seotan-ro, Seotan-myeon       SE DECISION MADE: 19-DEC-19
Pyeongtaek-Si  KR 17704           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveta Disposable Hysteroscope
Meditrina, Inc.                   510(k) NO: K192100(Special)
ATTN: Csaba  Truckai              PHONE NO : 408 4714877 
1190 Saratoga Avenue, Suite 180   SE DECISION MADE: 19-DEC-19
San Jose CA  95129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
Medline Industries, Inc.          510(k) NO: K192104(Traditional)
ATTN: Claire  Pigman              PHONE NO : 847 6434071 
Three Lakes Drive                 SE DECISION MADE: 23-DEC-19
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Icobrain
Icometrix NV                      510(k) NO: K192130(Traditional)
ATTN: Dirk  Smeets                PHONE NO : 32 16 369000 
Kolonel Begaultlaan 1b/12         SE DECISION MADE: 13-DEC-19
Leuven  BE 3012                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Beachside System
SeaSpine Orthopedics Corporation  510(k) NO: K192132(Traditional)
ATTN: Aly  Alvarez                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 03-DEC-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
MicroVention, Inc.                510(k) NO: K192135(Traditional)
ATTN: Sapna  Singh                PHONE NO : 714 2478162 
1311 Valencia Ave.                SE DECISION MADE: 24-DEC-19
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS Dental Implant System
Dentsply Sirona Inc.              510(k) NO: K192149(Traditional)
ATTN: Karl J. Nittinger           PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 11-DEC-19
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K192152(Traditional)
ATTN: Zhang  Wei                  PHONE NO : 86 755 81885655 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 13-DEC-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R&D Series Nova Compo N
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K192178(Traditional)
ATTN: Husamettin  Sonmez          PHONE NO : 0090 444 7130 
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 20-DEC-19
Konya  TR 42030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avenir Complete Hip System, Size 0 Coxa Vara
Zimmer, Inc.                      510(k) NO: K192189(Traditional)
ATTN: Rebecca D Noftz             PHONE NO : 574 3732934 
P.O. Box 708                      SE DECISION MADE: 18-DEC-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Radiation Dosimetry System microSTARii
Landauer                          510(k) NO: K192196(Traditional)
ATTN: Matt  Ennis                 PHONE NO : 1 800 3238830 
2 Science Rd.                     SE DECISION MADE: 27-DEC-19
Glenwood IL  60425                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReliOn Premier Classic Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K192220(Special)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100455 
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 13-DEC-19
Seoul  KR 06646                   510(k) STATEMENT
                                                    

DEVICE: BTL-899
BTL                               510(k) NO: K192224(Traditional)
ATTN: David  Chmel                PHONE NO : 866 2851656 
362 Elm Street                    SE DECISION MADE: 05-DEC-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
VizionFocus, Inc.                 510(k) NO: K192225(Traditional)
ATTN: Angus  Shih                 PHONE NO : 037 582900 
No.66, Youyi Rd.                  SE DECISION MADE: 09-DEC-19
Zhunan Township  TW 350           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System- GM Titanium Base for Bridge
JJGC Industria e Comercio de Mater510(k) NO: K192229(Traditional)
ATTN: Mariana Soares Hartmann     PHONE NO : 55 412169 4000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 19-DEC-19
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode System with Tone Applicator
InMode Ltd.                       510(k) NO: K192249(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 49097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 17-DEC-19
Yokneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Valve Sets
Zhejiang Chuangxiang Medical Techn510(k) NO: K192258(Traditional)
ATTN: Lucius  Long                PHONE NO : 86 057189 670888099 
301B, No.22, XinYan Road          SE DECISION MADE: 30-DEC-19
Hanzhou  CN 311100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ILUMIEN System with AptiVue Software version D.3
Abbott Medical                    510(k) NO: K192267(Special)
ATTN: Anita  Xavier               PHONE NO : 978 5773400 
4 Robbins Road                    SE DECISION MADE: 17-DEC-19
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PhantomMSK Trauma
OrthoGrid Systems Inc.            510(k) NO: K192279(Traditional)
ATTN: Sebastian  Edin             PHONE NO : 801 70035866 
3216 South Highland, Suite 202    SE DECISION MADE: 07-DEC-19
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transpara
Screenpoint Medical B.V.          510(k) NO: K192287(Traditional)
ATTN: Umar  Waqas                 PHONE NO : 31 24 3030045 
Mercator II, 7th floor, ToernooiveSE DECISION MADE: 10-DEC-19
Nijmegen  NL 6525EC               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halo One Thin-Walled Guiding Sheath
C.R. Bard, Inc.                   510(k) NO: K192313(Traditional)
ATTN: Elizabeth  Delahunty        PHONE NO : 353 53 9237111 
Moyne Upper                       SE DECISION MADE: 19-DEC-19
Enniscorthy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K192319(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 22194 1594 
3366, Hanseo-ro, Nam-myeon,       SE DECISION MADE: 10-DEC-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sheridan Spiral-Flex Endotracheal Tubes
TeleflexMedical, Inc              510(k) NO: K192324(Traditional)
ATTN: Lori  Pfohl                 PHONE NO : 919 4918960 
3015 Carrington Mill Blvd , Suite SE DECISION MADE: 06-DEC-19
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRACKER Kyphoplasty System
GS Medical Co., Ltd.              510(k) NO: K192335(Traditional)
ATTN: Andrea  Watt                PHONE NO : 82 352 3274641 
90, Osongsaengmyeong 4-ro         SE DECISION MADE: 04-DEC-19
Osong-eup, Cheongwon-gun  KR 363-9510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptoMonitor
Opsens Inc                        510(k) NO: K192340(Traditional)
ATTN: Marc  Chaunet               PHONE NO : 418 7810333 3408
750 Boulevard du Parc TechnologiquSE DECISION MADE: 12-DEC-19
Quebec  CA GIP 4S3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Monitor
Shenzhen Creative Industry Co., Lt510(k) NO: K192343(Traditional)
ATTN: Jia  Wang                   PHONE NO : 86 755 26433325 
Floor 5, BLD 9 Baiwangxin High-TecSE DECISION MADE: 31-DEC-19
Shenzhen  CN 518110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SICAT Implant V2.0
SICAT GmbH & Co. KG               510(k) NO: K192348(Traditional)
ATTN: Manfred  Breuer             PHONE NO : 49 228 85469782 
Brunnenallee 6                    SE DECISION MADE: 04-DEC-19
Bonn  DE 53177                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Airlock Centrolock Osteosynthesis Implant System
NOVASTEP                          510(k) NO: K192356(Traditional)
ATTN: Gilles  Audic               PHONE NO : 33 029933 8650 
Espace Performance III- Batiment PSE DECISION MADE: 14-DEC-19
Saint-Gregoire  FR 35769          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aero Blue Performance Surgical Gowns
O&M Halyard, Inc.                 510(k) NO: K192362(Abbreviated)
ATTN: Kimberly  Lewis             PHONE NO : 
9120 Lockwood Blvd                SE DECISION MADE: 13-DEC-19
Mechanicsville VA  23116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
Bayer Medical Care, Inc.          510(k) NO: K192370(Traditional)
ATTN: Alison  Maloney             PHONE NO : 862 4048106 
100 Bayer Blvd                    SE DECISION MADE: 13-DEC-19
Whippany NJ  07981                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
Cardinal Health 200, LLC          510(k) NO: K192374(Traditional)
ATTN: Dominic  Tunzi              PHONE NO : 312 2702172 
3651 Birchwood Drive              SE DECISION MADE: 02-DEC-19
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K192383(Traditional)
ATTN: Nimrod  Epstein             PHONE NO : 972 73 7946870 
3 Aminadav St.                    SE DECISION MADE: 20-DEC-19
Tel-Aviv  IL 6706703              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hi-Fatigue Bone Cement
OSARTIS GmbH                      510(k) NO: K192394(Traditional)
ATTN: Volker  Stirnal             PHONE NO : 49 6071 9290 
Lagerstrasse 11-15                SE DECISION MADE: 02-DEC-19
Dieburg  DE 64807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZS3 and z.one pro Ultrasound Systems
ShenZhen Mindray Bio-Medical Elect510(k) NO: K192410(Traditional)
ATTN: Jiang  Haosen               PHONE NO : 86 755 81886183 
Keji 12th Road South, High-tech InSE DECISION MADE: 19-DEC-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epic 980
Biolase, Inc.                     510(k) NO: K192430(Special)
ATTN: Alicia  Mszyca              PHONE NO : 949 2268471 
4 Cromwell                        SE DECISION MADE: 04-DEC-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JETi Peripheral Thrombectomy System
Walk Vascular, LLC                510(k) NO: K192439(Traditional)
ATTN: David  Look                 PHONE NO : 949 7529642 
17171 Daimler Street              SE DECISION MADE: 09-DEC-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FFRangio
CathWorks Ltd                     510(k) NO: K192442(Special)
ATTN: Asaf  Azulay                PHONE NO : 972 9 7467387 
3 Rapaport Street                 SE DECISION MADE: 09-DEC-19
Kfar-Saba  IL 4465141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dextile Anatomical Mesh
Sofradim Production               510(k) NO: K192443(Traditional)
ATTN: Benjamin  Rochette          PHONE NO : 33 474 089000 
116 avenue du Formans             SE DECISION MADE: 06-DEC-19
Trevoux  FR 01600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: mCare® Powder Free Nitrile Black Examination Glove
Mercator Medical (Thailand) LTD.  510(k) NO: K192444(Traditional)
ATTN: Praneet  Inthajak           PHONE NO : 66 74584 222 
88/8 Moo 12 Tambon Kampaengphet   SE DECISION MADE: 31-DEC-19
Amphur Rattaphum  TH 90180        510(k) STATEMENT
                                                    

DEVICE: Precision Casting Solutions Total Hip System
Precision Casting Solution, LLC   510(k) NO: K192450(Traditional)
ATTN: Jim  Moore                  PHONE NO : 503 4211251 
200031 Henrici Road               SE DECISION MADE: 17-DEC-19
Oregon City OR  97045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DenMat Orthodontic Aligners
DenMat Holdings, LLC              510(k) NO: K192470(Third Party - Traditional)
ATTN: Tom  Juarez                 PHONE NO : 805 3463700 
1017 W. Central Avenue            SE DECISION MADE: 20-DEC-19
Lompoc CA  93436                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RHIN1 Stylus
Aerin Medical Inc.                510(k) NO: K192471(Traditional)
ATTN: Matthew M Hull              PHONE NO : 737 2144035 
232 E Caribbean Dr.               SE DECISION MADE: 20-DEC-19
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exsomed Wrist Plating System
Exsomed Corporation               510(k) NO: K192473(Traditional)
ATTN: Michael  Zwolinski          PHONE NO : 855 3976633 
135 Columbia, Suite 201           SE DECISION MADE: 03-DEC-19
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elekta Unity
Elekta Limited                    510(k) NO: K192482(Traditional)
ATTN: Nicholas  Power             PHONE NO : 0044 1293 654422 
Fleming Way                       SE DECISION MADE: 05-DEC-19
Crawley  GB RH10 9RR              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioCode Respiratory Pathogen Panel (RPP)
Applied BioCode, Inc.             510(k) NO: K192485(Traditional)
ATTN: Robert Di Tullio            PHONE NO : 310 8011235 
10020 Pioneer Blvd Suite 102      SE DECISION MADE: 23-DEC-19
Santa Fe Springs CA  90670        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ-TRAX Containment Device
K1 Medical LLC                    510(k) NO: K192487(Traditional)
ATTN: Joseph  Azary               PHONE NO : 203 2426670 
56 Newton Road                    SE DECISION MADE: 23-DEC-19
Woodbridge CT  06525              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS50/HS60 Diagnostics Ultrasound System
Samsung Medison CO., LTD.         510(k) NO: K192505(Traditional)
ATTN: Scully  Kim                 PHONE NO : 82 2 21941312 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 12-DEC-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOSPA II Knee System
Corentec Co., Ltd                 510(k) NO: K192507(Traditional)
ATTN: J.S.  Daniel                PHONE NO : 82 41 5857144 
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 11-DEC-19
Cheonan-si  KR 31056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser 808nm
Beijing Superlaser Technology Co.,510(k) NO: K192516(Traditional)
ATTN: Shi  Shuang                 PHONE NO : 86 10 81284899 806
No. 2 Zhongfu Street, Economic andSE DECISION MADE: 10-DEC-19
Xihongmen Town, Daxing District, B510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intense Pulsed Light Treatment System
Shangdong Huamei Technology Co., L510(k) NO: K192521(Traditional)
ATTN: Xu  QingHua                 PHONE NO : 86 536211 0001 
No. 588, Changning Street, High-teSE DECISION MADE: 06-DEC-19
Weifang  CN 261205                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSV BellaTek Express and BellaTek Flex Abutments
Biomet 3i LLC                     510(k) NO: K192522(Traditional)
ATTN: Krupal  Patel               PHONE NO : 561 7766923 
4555 Riverside Drive              SE DECISION MADE: 09-DEC-19
Palm Beach Gardens FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Laser Therapy System
Shangdong Huamei Technology Co., L510(k) NO: K192528(Traditional)
ATTN: Xu  QingHua                 PHONE NO : 86 536 2110001 
No. 588, Changning Street, High-teSE DECISION MADE: 03-DEC-19
Weifang  CN 261205                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QyScore Software
Qynapse                           510(k) NO: K192531(Traditional)
ATTN: Olivier  Courreges          PHONE NO : 
67 rue Saint Jacques              SE DECISION MADE: 13-DEC-19
Paris  FR 75005                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Health Line CT CVC
Health Line International Corporat510(k) NO: K192533(Traditional)
ATTN: Joel K. Faulkner            PHONE NO : 801 7737798 
5675 W 300 S                      SE DECISION MADE: 10-DEC-19
Salt Lake City UT  84117          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deka Luxea
El..EN. Electronic Engineering SPA510(k) NO: K192539(Traditional)
ATTN: Paolo  Peruzzi              PHONE NO : 39 055 8226807 
via Baldanzese 17                 SE DECISION MADE: 16-DEC-19
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: decimal3D
.decimal, LLC.                    510(k) NO: K192554(Traditional)
ATTN: Kevin  Erhart               PHONE NO : 407 3303300 
121 Central Park PL               SE DECISION MADE: 13-DEC-19
Sanford FL  32771                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acetabular Bone Screws (for MobileLink Acetabular Cup System)
Waldemar Link GmbH & Co. KG       510(k) NO: K192559(Special)
ATTN: Karen  Sonnenberger         PHONE NO : 49 40 53995517 
Oststraße 4-10                    SE DECISION MADE: 21-DEC-19
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser Therapy System
San He Lefis Electronics Co., Ltd.510(k) NO: K192569(Traditional)
ATTN: Ning  Li                    PHONE NO : 86 188 11392951 
No. 1 Production Room., ChaoBai StSE DECISION MADE: 13-DEC-19
YanJiao Development Zone, Sanhe Co510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NemoScan
Software Nemotec S.L.             510(k) NO: K192571(Traditional)
ATTN: Carlos  Arias               PHONE NO : 34 91 4335222 
Juan de la Cierva Street, 66      SE DECISION MADE: 11-DEC-19
Arroyomolinos, Madrid  ES 28939   510(k) STATEMENT
                                                    

DEVICE: CNS Envision
Moberg Research, Inc.             510(k) NO: K192572(Traditional)
ATTN: Anna  Rodriguez             PHONE NO : 215 2830860 
224 S. Maple Street               SE DECISION MADE: 17-DEC-19
Ambler PA  19002                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InCore TMT System
Nextremity Solutions, Inc.        510(k) NO: K192578(Traditional)
ATTN: Elise  Fox                  PHONE NO : 574 3762062 
210 North Buffalo Street          SE DECISION MADE: 31-DEC-19
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
Ethicon, Inc                      510(k) NO: K192580(Traditional)
ATTN: Eleanor  Zhou               PHONE NO : 
Route 22 West, P.O. Box 151       SE DECISION MADE: 18-DEC-19
Somerville NJ  00876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEACON Caresystem Model 00002144
Mermaid Care A/S                  510(k) NO: K192584(Traditional)
ATTN: Claus  Lindholt             PHONE NO : 45 70 237015 
Hedelund 1                        SE DECISION MADE: 18-DEC-19
Norresundby  DK DK-0400           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Everyway OTC TENS/EMS Combination
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K192589(Traditional)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3 FL., NO. 5, Lane 155, Section 3,SE DECISION MADE: 19-DEC-19
Shenkeng District, New Taipei City510(k) STATEMENT
                                                    

DEVICE: ExSpiron 2Xi
Respiratory Motion                510(k) NO: K192595(Special)
ATTN: Susan K. Hamann             PHONE NO : 781 3731636 
80 Coolidge Hill Road             SE DECISION MADE: 17-DEC-19
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiteWalk
Viasonix Ltd.                     510(k) NO: K192607(Traditional)
ATTN: Shlomi  Deler               PHONE NO : 972 9744 1692 
10 Hamelacha Street               SE DECISION MADE: 19-DEC-19
Raananna  IL 4366105              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
Synovis Life Technologies, Inc. (B510(k) NO: K192615(Traditional)
ATTN: Megan  Sajjad               PHONE NO : 651 7967410 
2575 University Ave. W            SE DECISION MADE: 17-DEC-19
St. Paul MN  55114                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser Hair Growth Cap
Shang Fa Biotechnology Co.        510(k) NO: K192627(Traditional)
ATTN: Chung Ju Zhi                PHONE NO : 886 967 001688 
B1F., No. 6, Ln. 1, Qingli St., TuSE DECISION MADE: 13-DEC-19
New Taipei City  TW 23677         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinalytics
Optima Health Solutions Internatio510(k) NO: K192629(Traditional)
ATTN: Farhad  Ghani               PHONE NO : 1 604 2665338 
Unit 303 - 828 W 8th Avenue       SE DECISION MADE: 21-DEC-19
Vancouver  CA V5Z 1E2             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trigon™ Ti Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K192645(Traditional)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4754 Shavano Oak, Suite 101       SE DECISION MADE: 23-DEC-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neria guard Infusion Set
Unomedical a/s                    510(k) NO: K192647(Traditional)
ATTN: Mette Busk Henningsen       PHONE NO : 45 4022 1704 
Aaholmvej 1-3                     SE DECISION MADE: 13-DEC-19
Osted  DK DK-4320                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Depuy Synthes Maxillofacial Portfolio - MR Conditional
Synthes (USA) Products LLC        510(k) NO: K192655(Traditional)
ATTN: Satapa  Dhamankar           PHONE NO : 610 7196574 
1301 Goshen Parkway               SE DECISION MADE: 30-DEC-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K192666(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 12, Longtan Road, Cangqian StrSE DECISION MADE: 02-DEC-19
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Instrument Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K192670(Traditional)
ATTN: Luiza Vaccari Toppel        PHONE NO : 55 41 21694058 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 18-DEC-19
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Percusys® Plus Pedicle Screw System
Joimax GmbH                       510(k) NO: K192680(Traditional)
ATTN: Gary  Mocnik                PHONE NO : 949 4330413 
Amalienbadstr. 41, RaumFabrik 61  SE DECISION MADE: 18-DEC-19
Karlsruhe  DE 76227               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode System with the Morpheus8 (Fractora) Applicators
Inmode MD Ltd.                    510(k) NO: K192695(Special)
ATTN: Amit  Goren                 PHONE NO : 972 4909 7470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 27-DEC-19
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xcam
HDX WILL Corp.                    510(k) NO: K192700(Traditional)
ATTN: Myoung-Joon  Lee            PHONE NO : 82 43 7107318 
#105,106,201,202,203,204,38,OsongsSE DECISION MADE: 27-DEC-19
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dannik Titanium Ligation Clip
Dannik                            510(k) NO: K192711(Traditional)
ATTN: Olga  Haberlad              PHONE NO : 407 7451698 
941 W Morse Blvd. Suite 100       SE DECISION MADE: 20-DEC-19
Winter Park FL  32789             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
Pioneer Surgical Technology, Inc.,510(k) NO: K192718(Traditional)
ATTN: Linda  Busklein             PHONE NO : 888 4551061 
375 River Park Circle             SE DECISION MADE: 20-DEC-19
Marquette MI  49855-0627          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RelieforMe TENS/EMS Device Model UPK-GE01
Umeheal Ltd.                      510(k) NO: K192733(Traditional)
ATTN: Rui  Lin                    PHONE NO : 0086 0755 36646865 
Floor 5, Bld F4, 1001 ZhongshanyuaSE DECISION MADE: 23-DEC-19
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORRIDOR Fixation System
Globus Medical Inc.               510(k) NO: K192744(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 16-DEC-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soli-Lite LG4 Galileo
Silhouet-Tone Corporation         510(k) NO: K192755(Traditional)
ATTN: Eric  Ghedin                PHONE NO : 1 450 6879456 101
2185 Michelin                     SE DECISION MADE: 20-DEC-19
Laval  CA H7L 5B8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Physio Flex Annuloplasty Ring
Edwards Lifesciences LLC          510(k) NO: K192762(Traditional)
ATTN: Milinda  Mawley             PHONE NO : 949 2505847 
One Edwards Way                   SE DECISION MADE: 16-DEC-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT CaScoring
Siemens Medical Solutions USA, Inc510(k) NO: K192763(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 17-DEC-19
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Intraoral Imaging Plate System
Fsusen Technology Co., Ltd        510(k) NO: K192766(Traditional)
ATTN: Elsa  Li                    PHONE NO : 86 0755 29588956 
1F, 3# Building, Tongfuyu IndustriSE DECISION MADE: 05-DEC-19
Shenzhen  CN 518055               510(k) STATEMENT
                                                    

DEVICE: Temporary Fixation Pins
EiserTech, LLC                    510(k) NO: K192768(Traditional)
ATTN: Lukas  Eisermann            PHONE NO : 901 2218406 
9988 Hibert Street Suite 302      SE DECISION MADE: 26-DEC-19
San Diego CA  32131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLIVE
Nu Eyne Co., Ltd                  510(k) NO: K192773(Traditional)
ATTN: Dong Seong Lee              PHONE NO : 82 2 69538120 
#403, Seoul Biohub, 117-3 Hoegi-roSE DECISION MADE: 06-DEC-19
Seoul  KR 02455                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Demetra BDEM-01 Dermatoscope
Barco NV                          510(k) NO: K192829(Traditional)
ATTN: Julie  Vandecandelaere      PHONE NO : 32 56 262319 
President Kennedypark 35          SE DECISION MADE: 13-DEC-19
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indigo Aspiration System
Penumbra, Inc.                    510(k) NO: K192833(Traditional)
ATTN: Teri  Nguyen                PHONE NO : 510 9952012 
One Penumbra Place                SE DECISION MADE: 20-DEC-19
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SX-One MicroKnife
Sonex Health, Inc.                510(k) NO: K192873(Traditional)
ATTN: Aaron  Keenan               PHONE NO : 507 2191464 
11 1st Ave SW                     SE DECISION MADE: 20-DEC-19
Rochester MN  55902               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C.T.M. Mobility Scooter HS-268
Chien Ti Enterprise Co., Ltd.     510(k) NO: K192885(Traditional)
ATTN: Vivian  Lo                  PHONE NO : 886 2 29032987 
No. 13, Lane 227, Fu Ying Rd      SE DECISION MADE: 09-DEC-19
New Taipei City, Hsin Chuang Distr510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AutoMIStar
Apollo Medical Imaging Technology 510(k) NO: K192912(Third Party - Traditional)
ATTN: Qing  Yang                  PHONE NO : 61 3 99956190 
Suite 611 365 Little Collins StreeSE DECISION MADE: 31-DEC-19
Melbourne  AU Vic 3000            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
STERIS Corporation                510(k) NO: K192929(Special)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 10-DEC-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invictus™ Spinal Fixation System
Alphatec Spine, Inc.              510(k) NO: K192938(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 706 4946740 
5818 El Camino Real               SE DECISION MADE: 12-DEC-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Volumetric Specimen Imager
Clarix Imaging                    510(k) NO: K192939(Traditional)
ATTN: Xiao  han                   PHONE NO : 773 9542735 
2242 Harrison St Suite 201        SE DECISION MADE: 27-DEC-19
Chicago IL  60612                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEDIA Heroin Metabolite (6-AM) assay
Microgenics Corporation           510(k) NO: K192943(Traditional)
ATTN: Sharron  Penn               PHONE NO : 510 9795000 
46500 Kato Road                   SE DECISION MADE: 16-DEC-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Litho Evo
Quanta System spa                 510(k) NO: K192990(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
via Acquedotto 109                SE DECISION MADE: 20-DEC-19
Samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Albumin BCP
Sentinel CH. SpA                  510(k) NO: K193001(Traditional)
ATTN: Patricia  Dupe              PHONE NO : 39 02 34551496 
Via Robert Koch, 2                SE DECISION MADE: 19-DEC-19
Milano  IT 20152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monopolar Cord
New Deantronics Taiwan Ltd        510(k) NO: K193004(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 19-DEC-19
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Promisemed Heel Blood Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K193009(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571887 72985 
No. 12, Longtan Road, Cangqian StrSE DECISION MADE: 03-DEC-19
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Direct Hand-held Laparoscopic Instruments
Surgical Direct, Inc.             510(k) NO: K193018(Traditional)
ATTN: David  Murray               PHONE NO : 386 7381202 222
909 South Woodland Blvd.          SE DECISION MADE: 20-DEC-19
DeLand FL  32720                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VenaPro Vascular Therapy System
Innovamed Health, LLC             510(k) NO: K193020(Special)
ATTN: Luke  Zeutzius              PHONE NO : 972 7959269 
270 West 500 North                SE DECISION MADE: 04-DEC-19
North Salt Lake UT  84054         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDRAD Mark 7 Arterion Injection System
Bayer Medical Care Inc.           510(k) NO: K193028(Special)
ATTN: Kelly  Frank                PHONE NO : 412 5767583 
1 Bayer Drive                     SE DECISION MADE: 05-DEC-19
Indianola PA  15051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avenir Muller Stem, Avenir Cemented Hip Stem
Zimmer GmbH                       510(k) NO: K193030(Special)
ATTN: Roberto  Tommasini          PHONE NO : 41 58854 8264 
Sulzerallee 8                     SE DECISION MADE: 06-DEC-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Balloon Dilator V (with knife)
Olympus Medical Systems Corp.     510(k) NO: K193039(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-machi               SE DECISION MADE: 17-DEC-19
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
Zimmer GmbH                       510(k) NO: K193050(Special)
ATTN: Roberto  Tommasini          PHONE NO : 41 58 8548264 
Sulzerallee 8                     SE DECISION MADE: 26-DEC-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIROS 8 Sequential Compression Device
AIROS Medical, Inc.               510(k) NO: K193068(Special)
ATTN: Darren  Behuniak            PHONE NO : 1 866 9916956 
2501 Monroe Blvd. Suite 1200      SE DECISION MADE: 04-DEC-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIROS 6 Sequential Compression Device
AIROS Medical, Inc.               510(k) NO: K193069(Special)
ATTN: Darren  Behuniak            PHONE NO : 1 866 9916956 
2501 Monroe Blvd. Suite 1200      SE DECISION MADE: 04-DEC-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bashir Plus Endovascular Catheter
Thrombolex, Inc.                  510(k) NO: K193071(Traditional)
ATTN: Amy  Katsikis               PHONE NO : 267 8983986 
75 New Britain Dr.                SE DECISION MADE: 17-DEC-19
New Britain PA  18901             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
Medacta International SA          510(k) NO: K193083(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 03-DEC-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TriSalus Infusion System
TriSalus Life Sciences            510(k) NO: K193107(Third Party - Traditional)
ATTN: Patrick  McCain             PHONE NO : 703 3140030 
6272 W. 91st Avenue               SE DECISION MADE: 03-DEC-19
Westminster CO  80031             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MRopen EVO
ASG Superconductors S.p.A.        510(k) NO: K193116(Special)
ATTN: DeBenedetti  Luisella       PHONE NO : 39 010 6489358 
Corso Ferdinando Maria Perrone 73/SE DECISION MADE: 20-DEC-19
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Distal Cap Models 33-40
FUJIFILM Corporation              510(k) NO: K193123(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 11-DEC-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HI-TORQUE InfilTrac Guide Wire Family
Abbott Vascular                   510(k) NO: K193126(Special)
ATTN: Aniket  Khakhadiya          PHONE NO : 408 8458314 
3200 Lakeside Drive               SE DECISION MADE: 11-DEC-19
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
Hangzhou Clongene Biotech Co.,Ltd.510(k) NO: K193132(Traditional)
ATTN: Zheng  Shujian              PHONE NO : 86 571 88262120 
Building 4, No.20 Longquan Road, YSE DECISION MADE: 11-DEC-19
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
Cook Incorporated                 510(k) NO: K193133(Special)
ATTN: Irasema  Rivera             PHONE NO : 812 3353575 105116
750 Daniels Way                   SE DECISION MADE: 12-DEC-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSolution One Total Knee Application
Think Surgical, Inc.              510(k) NO: K193135(Special)
ATTN: Meliha  Mulalic             PHONE NO : 510 2492337 
47201 Lakeview Blvd               SE DECISION MADE: 11-DEC-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VaPro Plus Pocket, VaPro Plus
Hollister Incorporated            510(k) NO: K193148(Special)
ATTN: Michelle  Schiltz-Taing     PHONE NO : 847 6802122 
2000 Hollister Drive              SE DECISION MADE: 13-DEC-19
Libertyville IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True 3D Viewer Software
EchoPixel Inc.                    510(k) NO: K193149(Third Party - Traditional)
ATTN: Michael  Gabler             PHONE NO : 408 2058670 
4677 Old Ironsides Suite 445      SE DECISION MADE: 27-DEC-19
Santa Clara CA  95054             510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: Arthrex 3.9mm Corkscrew Suture Anchor
Arthrex Inc.                      510(k) NO: K193157(Special)
ATTN: Jessica L. Singelais        PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard          SE DECISION MADE: 12-DEC-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glidesheath Slender Tibial Pedal Kit
Terumo Medical Coporation         510(k) NO: K193160(Special)
ATTN: Liang  Lu                   PHONE NO : 410 3927321 
950 Elkton Blvd.                  SE DECISION MADE: 03-DEC-19
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPi-Sense Guided Coagulation System with VisiTrax
AtriCure, Inc.                    510(k) NO: K193162(Special)
ATTN: Caitlin  Wunderlin          PHONE NO : 513 7554100 
7555 Innovation Way               SE DECISION MADE: 13-DEC-19
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Luminex Molecular Diagnostics, Inc510(k) NO: K193167(Special)
ATTN: Jennifer  Grimes            PHONE NO : 1 437 3715516 
439 University Avenue             SE DECISION MADE: 11-DEC-19
Toronto  CA M5g 1y8               510(k) STATEMENT
                                                    

DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation   510(k) NO: K193170(Special)
ATTN: Tomohiro  Ito               PHONE NO : 262 42428222 
7-127, 4-Chome, Asahigaoka,       SE DECISION MADE: 13-DEC-19
Hino  JP 191-8503                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareView 1800Le
CareRay Digital Medical System Co.510(k) NO: K193173(Special)
ATTN: Leilei  Li                  PHONE NO : 86 512 86860288 
A2-201/B3-501, Biobay, 218 Xinghu SE DECISION MADE: 13-DEC-19
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Keos Lumbar IBFD
Keos                              510(k) NO: K193174(Special)
ATTN: Scott  Peterson             PHONE NO : 239 2591491 
1824 Colonial Village Lane        SE DECISION MADE: 16-DEC-19
Lancaster PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EV1000 Clinical Platform
Edwards Lifesciences, LLC         510(k) NO: K193179(Special)
ATTN: Jamie  Byun                 PHONE NO : 949 2500808 
One Edwards Way                   SE DECISION MADE: 17-DEC-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossTorq 14 Guidewire
Scientia Cardio Access LLC        510(k) NO: K193194(Third Party - Traditional)
ATTN: Amy  McManus                PHONE NO : 1 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 13-DEC-19
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EXALT Model D Single-Use Duodenoscope, EXALT Controller
Boston Scientific Corporation     510(k) NO: K193202(Traditional)
ATTN: Carter  Navarro             PHONE NO : 508 6834793 
100 Boston Scientific Way         SE DECISION MADE: 13-DEC-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G Surgical Marksman System
G Surgical LLC                    510(k) NO: K193219(Special)
ATTN: Donald  Grafton             PHONE NO : 512 4944749 
9433 Bee Cave Road Building 3, SuiSE DECISION MADE: 17-DEC-19
Austin TX  78733                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ziehm Vision FD
Ziehm Imaging GmbH                510(k) NO: K193230(Special)
ATTN: Steve  Seeman               PHONE NO : 49 0911 2172 219
Donaustrasse 31                   SE DECISION MADE: 20-DEC-19
Nuremberg  DE 90451               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Telepack +
Karl Storz Endoscopy America, Inc.510(k) NO: K193235(Special)
ATTN: Winkie  Wong                PHONE NO : 424 2188379 
2151 E. Grand Ave                 SE DECISION MADE: 20-DEC-19
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexus DR Digital X-Ray Imaging System (with vSharp)
Varex Imaging Corporation         510(k) NO: K193238(Special)
ATTN: Michael Van Ryn             PHONE NO : 315 2346800 
121 Metropolitan Drive            SE DECISION MADE: 20-DEC-19
Liverpool NY  13088               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Steam Chemical Integrator
3M Company                        510(k) NO: K193254(Special)
ATTN: Mary  Fretland              PHONE NO : 651 7372296 
3M Center, Building 275-5W-06     SE DECISION MADE: 23-DEC-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroLift System (UL400)
Neotract, Inc.                    510(k) NO: K193269(Special)
ATTN: Brian  Gall                 PHONE NO : 925 3296547 
4155 Hopyard Rd.                  SE DECISION MADE: 20-DEC-19
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comet II Pressure Guidewire
Boston Scientific Corporation     510(k) NO: K193279(Special)
ATTN: Kimberly  Berg              PHONE NO : 763 4942701 
Three Scimed Place                SE DECISION MADE: 23-DEC-19
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
Applied Medical Resources Corp.   510(k) NO: K193292(Special)
ATTN: Blake  Stacy                PHONE NO : 949 7138163 
22872 Avenida Empresa             SE DECISION MADE: 20-DEC-19
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreLite X-Ray Specimen Cabinet
Cirdan Imaging Limited            510(k) NO: K193317(Third Party - Traditional)
ATTN: Jenna  McGarry              PHONE NO : 011 4428 92660880 
8 Enterprise Crescent, BallinderrySE DECISION MADE: 13-DEC-19
Lisburn  GB BT28 2BP              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Tri-Ex Extraction Balloon with Multiple Sizing
Wilson-Cook Medical Inc.          510(k) NO: K193344(Special)
ATTN: Theresa  de Prat            PHONE NO : 336 7440157 396518
4900 Bethania Station Road        SE DECISION MADE: 13-DEC-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadCalc Software
LifeLine Software, Inc.           510(k) NO: K193381(Special)
ATTN: Craig  Laughton             PHONE NO : 903 2074298 13
3304 S Broadway Ave, Suite 200    SE DECISION MADE: 31-DEC-19
Tyler TX  75701                   510(k) STATEMENT
                                                    

DEVICE: UroNav System
Invivo Corporation                510(k) NO: K193403(Third Party - Traditional)
ATTN: Kym  Rupp                   PHONE NO : 452 87 7127
3545 SW 47th Ave                  SE DECISION MADE: 27-DEC-19
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


       TOTAL 510(k)s THIS PERIOD   265                                     
       TOTAL WITH SUMMARIES        249                                     
       TOTAL WITH STATEMENTS        16
                                      
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