Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 50
- Latest Decision
- 2017-07-21
Clearances · page 21 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | FDT | Class II | 2017-07-21 |
| K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | FER | Class II | 2017-07-20 |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | FIE | Class II | 2017-07-20 |
| K170379 | Disposable Standard Clamp | Standard Bariatrics | GCJ | Class II | 2017-07-19 |
| K163057 | Relizorb | Alcresta Therapeutics, Inc. | PLQ | Class II | 2017-07-12 |
| K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | FBK | Class II | 2017-07-07 |
| K161349 | Everyway Incontinence Stimulation System | Everyway Medical Instrument Co., Ltd. | KPI | Class II | 2017-07-07 |
| K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | LJH | Class II | 2017-07-07 |
| K170122 | Delta III Lithotripter | Dornier Medtech America | LNS | Class II | 2017-06-28 |
| K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | FAD | Class II | 2017-06-22 |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | ODE | Class II | 2017-06-22 |
| DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | NOY | Class II | 2017-06-21 |
| K162588 | Möller Medical Biopsy Needles and Systems | Moller Medical GmbH | KNW | Class II | 2017-06-19 |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | FJK | Class II | 2017-06-16 |
| K171223 | Quantum TTC Biliary Balloon Dilator | Wilson-Cook Medical, Inc. | FGE | Class II | 2017-06-16 |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | Fujifilm Medical Systems U.S.A, Inc. | FDS | Class II | 2017-06-15 |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | FCG | Class II | 2017-06-14 |
| K170713 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2017-06-13 |
| K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree | Intuitive Surgical, Inc. | NAY | Class II | 2017-06-13 |
| K162109 | Kwart Retro-Inject Ureteral Stent | Cook Incorporated | FAD | Class II | 2017-06-07 |
| K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | Xeridiem Medical Devices | PIF | Class II | 2017-06-06 |
| K171344 | Xenocor Xenoscope Laparoscopic System | Xenocor, Inc. | GCJ | Class II | 2017-06-01 |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) | Pall International Sarl | NHV | Class II | 2017-06-01 |
| K171388 | EndoWrist Stapler 45 System and Stapler 45 Reloads | Intuitive Surgical, Inc. | NAY | Class II | 2017-05-31 |
| K170899 | 27HJ713S | Lg Electronics | GCJ | Class II | 2017-05-30 |
| K171294 | da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2017-05-26 |
| K170839 | RAPID Web | Given Imaging , Ltd. | NEZ | Class II | 2017-05-26 |
| K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | OWN | Class II | 2017-05-25 |
| K163257 | VitreOx Anti-fog Solution | Sio2 Nanotech, LLC | OCT | Class II | 2017-05-24 |
| K163090 | Plasma Edge System | Chirurgie Innovation | FAS | Class II | 2017-05-23 |
| K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Cook Incorporated | KNT | Class II | 2017-05-18 |
| K160567 | Barone Jejunostomy Catheter Set | Cook Incorporated | KNT | Class II | 2017-05-18 |
| K162716 | bibag | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2017-05-18 |
| K171165 | SmartByte Device | Scientific Intake | ONY | Class II | 2017-05-18 |
| K163002 | Kangaroo Feeding Tube with IRIS Technology | Covidien (Dba Medtronic) | KNT | Class II | 2017-05-16 |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | KGE | Class II | 2017-05-09 |
| K170469 | NxStage System One Plus | Nxstage Medical, Inc. | KDI | Class II | 2017-05-09 |
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | FGE | Class II | 2017-05-08 |
| K171076 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | FGB | Class II | 2017-05-05 |
| K161770 | Rusch Silicone Foley Catheter | Teleflexmedical, Inc. | EZL | Class II | 2017-05-05 |
| K162254 | Cedic Enteral ENFit Transition Connectors | Cedic S.R.L. | PIO | Class II | 2017-05-04 |
| K162330 | Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | FDF | Class II | 2017-05-04 |
| K162248 | Asahi ViE-U Series Dialyzer | Asahi Kasei Medical Co., Ltd. | KDI | Class II | 2017-05-03 |
| K163530 | PrisMax Control Unit | Baxter Healthcare Corp | KDI | Class II | 2017-05-03 |
| K162120 | Scope-Assist Flushing Sink | Custom Ultrasonics, Inc. | FEB | Class II | 2017-04-28 |
| K162142 | Accessory Irrigation Adapter | Wilson-Cook Medical, Inc. | ODC | Class II | 2017-04-27 |
| K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | FET | Class II | 2017-04-25 |
| K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | FAD | Class II | 2017-04-24 |
| K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | NAY | Class II | 2017-04-21 |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | FFX | Class II | 2017-04-17 |
| K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner | Pentax of America, Inc. | ODG | Class II | 2017-04-13 |
| K170598 | ZeroWire Mobile | Nds Surgical Imaging, LLC | GCJ | Class II | 2017-04-07 |
| K153763 | Howell Biliary Aspiration Needle | Wilson-Cook Medical, Inc. | FCK | Class II | 2017-04-06 |
| K162488 | Optiflux dialyzer | Fresenius Medical Care North America | KDI | Class II | 2017-04-06 |
| K163458 | Zenysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | MPB | Class II | 2017-04-04 |
| K162471 | Hach CM130 Chlorine Monitoring System | Hach Company | PSX | Class II | 2017-03-30 |
| K170743 | AngioDynamics Total Abscession Biliary Drainage Catheter | AngioDynamics, Inc. | FGE | Class II | 2017-03-30 |
| K163052 | Brevera Biopsy System with Corlumina Imaging Technology | Hologic, Inc. | KNW | Class II | 2017-03-29 |
| K162979 | Veloxion System | Corinth Medtech, Inc. | FJL | Class II | 2017-03-24 |
| K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT | Pentaferte Italia S.R.L. | PNR | Class II | 2017-03-22 |
| K161979 | ENFit enteral syringe | Jiangyin Caina Technology Co., Ltd. | PNR | Class II | 2017-03-22 |
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm | Avitus Orthopaedics, Inc. | KNW | Class II | 2017-03-20 |
| K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector | Trovrx, Inc. Dba Trovita Health Science | PIF | Class II | 2017-03-17 |
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | FFX | Class II | 2017-03-14 |
| K161785 | THD ANOPRESS | Thd Spa | KLA | Class II | 2017-03-14 |
| K162836 | FUJIFILM Surgical System | Fujifilm New Development U.S.A., Inc. | GCJ | Class II | 2017-03-13 |
| K170030 | NOVATECH TALCAIR | Novatech SA | GCJ | Class II | 2017-03-13 |
| K163495 | AdvanCE capsule endoscope delivery device | United States Endoscopy Group, Inc. | NEZ | Class II | 2017-03-10 |
| K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads | Intuitive Surgical, Inc. | NAY | Class II | 2017-03-10 |
| K170084 | InterLock Trocar | Fujifilm New Development U.S.A., Inc. | GCJ | Class II | 2017-03-10 |
| K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar | Covidien, LLC | GCJ | Class II | 2017-03-08 |
| K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | KNT | Class II | 2017-03-07 |
| K161304 | EndoPur Filter | Nephros, Inc. | FIP | Class II | 2017-03-02 |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | KNY | Class II | 2017-03-02 |
| K153688 | Edi Catheter ENFit | Maquet Critical Care AB | PIF | Class II | 2017-03-02 |
| K170008 | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set | Cook Incorporated | KNW | Class II | 2017-02-28 |
| K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | EZL | Class II | 2017-02-24 |
| K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | 2017-02-18 |
| K170103 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | GCJ | Class II | 2017-02-16 |
| K161811 | Medela Low Dose Enteral Syringe | Medela, Inc. | PNR | Class II | 2017-02-15 |
| K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | KNT | Class II | 2017-02-09 |
| K160444 | FB-U Hemodialyzer | Nipro Medical Corporation | KDI | Class II | 2017-02-08 |
| K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | Cook Ireland, Ltd. | FGE | Class II | 2017-02-07 |
| K162973 | EndoWrist Suction Irrigator | Intuitive Surgical, Inc. | NAY | Class II | 2017-02-06 |
| K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | ODG | Class II | 2017-01-30 |
| K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | FAD | Class II | 2017-01-27 |
| K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | OWN | Class II | 2017-01-26 |
| K163179 | Onli Intermittent Catheter | Hollister Incorporated | GBM | Class II | 2017-01-26 |
| K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | 2017-01-25 |
| K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corp. | NEZ | Class II | 2017-01-19 |
| K161178 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2017-01-19 |
| K162197 | EndoClot | Endoclot Plus Co., Ltd. | GCJ | Class II | 2017-01-18 |
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. | OWN | Class II | 2017-01-11 |
| K161204 | ENDOCAM Flex HD Camera System 5521 | Richard Wolf Medical Instruments Corporation | FET | Class II | 2017-01-11 |
| K162387 | U-IGNITE Bladeless Trocar | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | GCJ | Class II | 2017-01-11 |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear | United States Endoscopy Group, Inc. | FDF | Class II | 2017-01-06 |
| K161463 | SureClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2017-01-06 |
| K162887 | PrismaSATE | Baxter Healthcare Corporation | KPO | Class II | 2017-01-06 |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | Cook Incorporated | MPB | Class II | 2017-01-06 |
| K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON | United State Endoscopy Group, Inc. | FEQ | Class II | 2017-01-04 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.