Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 56
- Latest Decision
- 2019-11-07
Clearances · page 16 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | Bard Peripheral Vascular, Inc. | KNW | Class II | 2019-11-07 |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | PIF | Class II | 2019-11-07 |
| K192891 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | GCJ | Class II | 2019-11-07 |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | EZL | Class II | 2019-11-06 |
| K191312 | Perfect PFE | Tenscare, Ltd. | KPI | Class II | 2019-11-01 |
| K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | NHV | Class II | 2019-10-25 |
| K192705 | MiniCap Extended Life PD Transfer Sets | Baxter Healthcare | KDJ | Class II | 2019-10-25 |
| K192722 | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | STERIS Corporation | PKL | Class II | 2019-10-24 |
| K183309 | stentfix OTSC System Set | Ovesco Endoscopy AG | PKL | Class II | 2019-10-22 |
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | Pentax Medical | FDT | Class II | 2019-10-21 |
| K190084 | McLean-Ring Enteral Feeding Tube Set | Cook Incorporated | KNT | Class II | 2019-10-11 |
| K183171 | ScopeSeal Duodenoscope Protective Device | Gi Scientific, LLC | ODB | Class II | 2019-10-08 |
| K190060 | Urethrotech UCD | Urethrotech | EZL | Class II | 2019-10-04 |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | FIP | Class II | 2019-10-03 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | FFX | Class II | 2019-10-03 |
| K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | KGC | Class II | 2019-09-30 |
| K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | FDT | Class II | 2019-09-27 |
| K190029 | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | GCJ | Class II | 2019-09-26 |
| K183675 | 3D Visualization System | Scivita Medical Technology Co., Ltd. | GCJ | Class II | 2019-09-25 |
| K191006 | EasiSlush | Bridge TO Life, Ltd. | KDN | Class II | 2019-09-24 |
| K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | FAJ | Class II | 2019-09-18 |
| K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | EYB | Class II | 2019-09-18 |
| K192059 | Bio Guard Air/Water & Suction Valves | United States Endoscopy Group, Inc. | ODC | Class II | 2019-09-17 |
| K192172 | Connected OR Hub with Device and Voice Control | Stryker | GCJ | Class II | 2019-09-09 |
| K191366 | Vacutore Air/Water Bottle Tubing | Smartdata Suzhou Co., Ltd. | OCX | Class II | 2019-09-06 |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | ODG | Class II | 2019-09-05 |
| K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | FED | Class II | 2019-08-30 |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | Olympus Medical Systems Corp. | FET | Class II | 2019-08-30 |
| K191439 | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery | OCW | Class II | 2019-08-29 |
| K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | 2019-08-26 |
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | FJI | Class II | 2019-08-23 |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | Smith and Nephew, Inc. | GCJ | Class II | 2019-08-23 |
| K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | STERIS Corporation | NVE | Class II | 2019-08-21 |
| K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | FAD | Class II | 2019-08-16 |
| K191200 | TULSA-PRO System | Profound Medical, Inc. | PLP | Class II | 2019-08-15 |
| K190063 | Servator C SALF Solution | S.A.L.F. Spa | MSB | Class II | 2019-08-14 |
| K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | KDI | Class II | 2019-08-09 |
| K181760 | Transit-Pellets | Medifactia AB | FFX | Class II | 2019-08-08 |
| K191295 | Percutaneous Introducer Needle | Progressive Medical, Inc. | GCJ | Class II | 2019-08-06 |
| K190502 | ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co.,Ltd | PNR | Class II | 2019-08-06 |
| K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | EYB | Class II | 2019-08-05 |
| K191496 | TDS Standard Solution | Mesa Laboratories, Inc. | FKH | Class II | 2019-08-05 |
| K191505 | Rezum System | Nxthera (A Boston Scientific Company) | KNS | Class II | 2019-08-02 |
| K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip | Olympus Medical Systems Corp. | PKL | Class II | 2019-08-01 |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | United States Endoscopy Group, Inc. | FEQ | Class II | 2019-08-01 |
| K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | Intuitive Surgical | NAY | Class II | 2019-07-26 |
| K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | KDI | Class II | 2019-07-25 |
| K191789 | Stonetome Stone Removal Device | Boston Scientific Corporation | LQR | Class II | 2019-07-25 |
| K191078 | BAROnova Access Sheath Kit | Baronova, Inc. | QGG | Class II | 2019-07-22 |
| K182940 | Surdial DX Hemodialysis System | Nipro Medical Corporation | KDI | Class II | 2019-07-19 |
| K191633 | Infyna Chic | Hollister Incorporated | GBM | Class II | 2019-07-19 |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical, Inc. | FDI | Class II | 2019-07-18 |
| K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | FFL | Class II | 2019-07-18 |
| K183572 | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L | Fujifilm Corporation | FDS | Class II | 2019-07-16 |
| K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | Intuitive Surgical, Inc. | NAY | Class II | 2019-07-12 |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | KNW | Class II | 2019-07-12 |
| K181457 | EndoStream(TM) | Partnership Medical Limited | OCX | Class II | 2019-07-11 |
| K191482 | Senhance Surgical System | Transenterix, Inc. | NAY | Class II | 2019-07-11 |
| K181418 | ScopeFlow Pure(TM) | Partnership Medical Limited | OCX | Class II | 2019-07-11 |
| K190620 | SpeediCath Flex Coude Pro | Coloplast | GBM | Class II | 2019-07-10 |
| K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | FEB | Class II | 2019-07-09 |
| K190645 | Arthrex NanoScope System | Arthrex, Inc. | GCJ | Class II | 2019-07-05 |
| K182876 | Uro-N Cystoscope | Uroviu Corporation | FAJ | Class II | 2019-07-02 |
| K183021 | ClearEndoclip | Finemedix Co., Ltd. | PKL | Class II | 2019-06-28 |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | Erbe USA, Inc. | OCX | Class II | 2019-06-27 |
| K191485 | Deflectable Brush Biopsy Set | Cook Incorporated | FDX | Class II | 2019-06-26 |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | KGC | Class II | 2019-06-26 |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BT | Fujifilm Corporation | FDA | Class II | 2019-06-24 |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | KNS | Class II | 2019-06-21 |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | EYB | Class II | 2019-06-17 |
| K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | KNT | Class II | 2019-06-14 |
| K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | NIE | Class II | 2019-06-14 |
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube Mark IV | Moss Tubes, Inc. | PIF | Class II | 2019-06-14 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | FJL | Class II | 2019-06-13 |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | GBM | Class II | 2019-06-12 |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, | Ranfac Corporation | KNW | Class II | 2019-06-12 |
| DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | QHH | Class II | 2019-06-07 |
| K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | Smartdata Suzhou Co., Ltd. | ODC | Class II | 2019-06-07 |
| K191043 | da Vinci Handheld Camera | Intuitive Surgical, Inc. | GCJ | Class II | 2019-06-06 |
| K191220 | Pure Vu System | Motus GI Medical Technologies , Ltd. | FDF | Class II | 2019-06-06 |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | OCV | Class II | 2019-06-05 |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | Avanos Medical, Inc. | KNT | Class II | 2019-06-04 |
| K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | PIF | Class II | 2019-05-31 |
| K182443 | Pristine Hemodialysis Catheter | Pristine Access Technologies , Ltd. | MSD | Class II | 2019-05-31 |
| K190831 | E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | GCJ | Class II | 2019-05-31 |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | Boddingtons Plastics, Ltd. | FED | Class II | 2019-05-30 |
| K182403 | Peel-Away Introducer | Cook Incorporated | FED | Class II | 2019-05-29 |
| K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | KNT | Class II | 2019-05-29 |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | FFK | Class II | 2019-05-29 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | KOD | Class II | 2019-05-24 |
| K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | FAD | Class II | 2019-05-24 |
| K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix | Bioncise NV | KNW | Class II | 2019-05-24 |
| K190469 | ERBEFLO 2 Disposable Tubing System | Erbe USA, Inc. | OCX | Class II | 2019-05-23 |
| K190367 | Smith & Nephew Tablet Application | Smith & Nephew | QGY | Class II | 2019-05-21 |
| K182520 | Flexible Overtube | Sumitomo Bakelite Co., Ltd. | FED | Class II | 2019-05-15 |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | Olympus Medical Systems Corp. | KNS | Class II | 2019-05-15 |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | FCX | Class II | 2019-05-14 |
| K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker | OWN | Class II | 2019-05-10 |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | GBM | Class II | 2019-05-08 |
| K191011 | Scope ProTech | Meditech Endoscopy, Ltd. | OCU | Class II | 2019-05-07 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.