Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 48
- Latest Decision
- 2015-11-06
Clearances · page 24 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | PLP | Class II | 2015-11-06 |
| K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | Nds Surgical Imaging, LLC | GCJ | Class II | 2015-11-06 |
| K151925 | Elation Wireguided Balloon Dilation Catheter | Merit Medical Systems, Inc. | FGE | Class II | 2015-11-06 |
| K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care North America | KOC | Class II | 2015-11-05 |
| K152580 | rescuenet | Endochoice, Inc. | FDI | Class II | 2015-11-03 |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER | Baxter Healthcare | KDJ | Class II | 2015-10-29 |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | Baxter Healthcare Corporation | KDJ | Class II | 2015-10-29 |
| K152367 | Optiflux dialyzer | Fresenius Medical Care North America | KDI | Class II | 2015-10-29 |
| K152204 | VS3-IR system | Visionsense, Ltd. | OWN | Class II | 2015-10-28 |
| K152607 | Express SD Biliary Monorail Premounted Stent System | Boston Scientific | FGE | Class II | 2015-10-27 |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | FAS | Class II | 2015-10-26 |
| K151489 | Retrieval bag system | Beacon Surgical, Inc. | GCJ | Class II | 2015-10-26 |
| K151593 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | OWN | Class II | 2015-10-23 |
| K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | KNW | Class II | 2015-10-23 |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | FCG | Class II | 2015-10-22 |
| K143617 | AquaC UNO H | Vivonic GmbH | FIP | Class II | 2015-10-19 |
| K152663 | Bladeless Optical Obturators | Intuitive Surgical, Inc. | GCJ | Class II | 2015-10-16 |
| K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | 2015-10-16 |
| K152035 | iSnare system-Lariat | United States Endoscopy Group, Inc. | FBK | Class II | 2015-10-15 |
| K152140 | Boa Endoscopic Valve | C2 Therapeutics, Inc. | OCX | Class II | 2015-10-13 |
| K152109 | HD-Camera HDC1000 | W.O.M. World of Medicine GmbH | FET | Class II | 2015-10-13 |
| K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | FKX | Class II | 2015-10-09 |
| K152565 | Auto Suture Locking Trocar | Covidien | GCJ | Class II | 2015-10-09 |
| DEN150011 | Sonablate 450 | Sonacare Medical, LLC | PLP | Class II | 2015-10-09 |
| K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | KNS | Class II | 2015-10-08 |
| K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | Covidien | PIF | Class II | 2015-10-08 |
| K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | PCU | Class II | 2015-10-06 |
| K150221 | EPX-4440HD and EPX-4400HD with FICE | Fujifilm Medical System U.S.A., Inc. | FET | Class II | 2015-10-01 |
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set | Cook Incorporated | FGE | Class II | 2015-09-30 |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | Navilyst Medical, Inc. | FGE | Class II | 2015-09-24 |
| K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | FIP | Class II | 2015-09-23 |
| K150657 | Phoenix XL Dialysate Meter | Mesa Laboratories, Inc. | FIZ | Class II | 2015-09-21 |
| K151728 | CoStorSol plus G | Preservation Solutions, Inc. | KDN | Class II | 2015-09-18 |
| K151471 | Radifocus Glidewire Endoscopic Wire | Terumo Medical Corporation | OCY | Class II | 2015-09-17 |
| K143640 | KSEA CMOS Camera System (C-cam) | KARL STORZ Endoscopy-America, Inc. | GCJ | Class II | 2015-09-17 |
| K150067 | OTSC Proctology | Ovesco Endoscopy AG | PKL | Class II | 2015-09-16 |
| K150381 | AQUA CLEANSE | Quality Medical Supply, Inc. | KPL | Class II | 2015-09-11 |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical , Ltd. | MPA | Class II | 2015-09-11 |
| K151990 | Tissue Removal System | Boehringer Laboratories, LLC | GCJ | Class II | 2015-09-11 |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | Hollister Incorporated | GBM | Class II | 2015-09-09 |
| K151822 | ab medica irrigation/suction gravity system | Ab Medica Sas | GCJ | Class II | 2015-09-04 |
| K150852 | SIC 8000 | Cosmo Technologies, Ltd. | PLL | Class II | 2015-09-03 |
| K140310 | Peristeen Anal Irrigation System | Coloplast A/S | KNT | Class II | 2015-09-03 |
| K150786 | Rezum System | Nxthera, Inc. | KNS | Class II | 2015-08-27 |
| K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve | United States Endoscopy Group, Inc. | ODC | Class II | 2015-08-25 |
| K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | GCJ | Class II | 2015-08-20 |
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | Stryker Endoscopy | FCS | Class II | 2015-08-20 |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | FDA | Class II | 2015-08-20 |
| K150169 | Sertera Biopsy Device | Hologic, Inc. | KNW | Class II | 2015-08-14 |
| K151801 | Arc Endocuff Vision | Boddingtons Plastics, Ltd. | FED | Class II | 2015-08-13 |
| K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar | Unimicro Medical Systems (Shenzhen) Co., Ltd. | GCJ | Class II | 2015-08-10 |
| K151373 | Corvocet Coaxial Introducer | Merit Medical Systems, Inc. | FCG | Class II | 2015-08-07 |
| K151802 | Resolution Clip | Boston Scientific Corporation | PKL | Class II | 2015-08-06 |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | PCU | Class II | 2015-08-05 |
| K151298 | Gemini XXP-HP | Dornier Medtech America | LNS | Class II | 2015-07-30 |
| K151889 | Infinity ERCP Sampling Device | United States Endoscopy Group, Inc. | FDX | Class II | 2015-07-30 |
| K150316 | Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | FDI | Class II | 2015-07-30 |
| K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor | Sony Electronics, Inc. | GCJ | Class II | 2015-07-29 |
| K150699 | Bard LubriGuard Foley Catheter | C.R. Bard, Inc. | EZL | Class II | 2015-07-28 |
| K151628 | Medline ENFit Connectors | Medline Industries, Inc. | PIO | Class II | 2015-07-24 |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | NIE | Class II | 2015-07-24 |
| K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | KNT | Class II | 2015-07-21 |
| K150088 | Evacore Fully Disposable Vacuum Assist Biopsy Device | Pin-Point Care Corp. | KNW | Class II | 2015-07-20 |
| K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector | Covidien | PIF | Class II | 2015-07-13 |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | KLA | Class II | 2015-07-07 |
| K151197 | Lariat snare | United States Endoscopy Group, Inc. | FDI | Class II | 2015-07-06 |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | FDF | Class II | 2015-07-06 |
| K150935 | SpeediCath Compact Eve | Coloplast A/S | GBM | Class II | 2015-07-02 |
| K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | Covidien | GCJ | Class II | 2015-07-02 |
| K143474 | Artemis Hand Held Imaging System | Quest Medical Imaging | OWN | Class II | 2015-06-30 |
| K142548 | MIDSLEEVE | Medical Innovation Development | KNT | Class II | 2015-06-23 |
| K150781 | Tissue Removal Pouch | Boehringer Laboratories, LLC | GCJ | Class II | 2015-06-19 |
| K151356 | Spacemaker Pro Access and Dissector System | Covidien, LLC | GCJ | Class II | 2015-06-18 |
| K142369 | Urinary Incontinence System | Guangzhou Finecure Medical Equipment Co.,Ltd | KPI | Class II | 2015-06-17 |
| K150018 | VS3-IR-MMS System | Visionsense, Ltd. | OWN | Class II | 2015-06-17 |
| K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | FHN | Class II | 2015-06-12 |
| K150569 | LaparoVue | Buffalo Filter, LLC | GCJ | Class II | 2015-06-10 |
| K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | PIO | Class II | 2015-06-09 |
| K150625 | Morrison Steerable Needle | Apriomed AB | KNW | Class II | 2015-06-09 |
| K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | OCZ | Class II | 2015-06-08 |
| K142327 | smARTrack Feeding Tube System | Art Healthcare , Ltd. | KNT | Class II | 2015-06-08 |
| K151001 | MUSE System | Medigus , Ltd. | ODE | Class II | 2015-06-05 |
| K150472 | NxStage System One | Nxstage Medical, Inc. | ODN | Class II | 2015-06-04 |
| K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | FBK | Class II | 2015-06-02 |
| K150549 | Reactor(TM) Trocar and Sleeve | Sharp Medical Prducts, LLC | GCJ | Class II | 2015-06-01 |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | NIE | Class II | 2015-06-01 |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector | Boston Scientific Corp | PIF | Class II | 2015-05-29 |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | Coloplast A/S | OCY | Class II | 2015-05-27 |
| K142971 | AMT Bridle - Nasal Tube Retention System | Applied Medical Technology, Inc. | KNT | Class II | 2015-05-26 |
| K141902 | LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER | Lagis Enterprises Co, Ltd. | GCJ | Class II | 2015-05-26 |
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | KNW | Class II | 2015-05-22 |
| K150284 | IS4000 da Vinci EndoWrist Instruments | Intuitive Surgical, Inc. | NAY | Class II | 2015-05-15 |
| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | Fujifilm Medical System U.S.A., Inc. | FDS | Class II | 2015-05-14 |
| K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | FIE | Class II | 2015-05-13 |
| K150345 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | EZD | Class II | 2015-05-11 |
| K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-CORE | Biologic Therapies, Inc. | KNW | Class II | 2015-05-04 |
| K150880 | Tablo Console with Wireless Capability | Outset Medical | KDI | Class II | 2015-05-01 |
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | FCG | Class II | 2015-05-01 |
| K150633 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | GCJ | Class II | 2015-04-29 |
| K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | Intuitive Surgical, Inc. | NAY | Class II | 2015-04-29 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.