Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 47
- Latest Decision
- 2026-10-02
Clearances · page 1 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260487 | stentFIX System Set (100.50n) | Ovesco Endoscopy AG | PKL | Class II | 2026-10-02 |
| K261783 | Plenity-V (MC0979 / GS110) | Gelesis SRL | QFQ | Class II | 2026-10-02 |
| K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | Steris | FEB | Class II | 2026-10-02 |
| K261741 | Hemostatic Clip | Anrei Medical (Hz) Co., Ltd. | PKL | Class II | 2026-10-02 |
| K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | KNT | Class II | 2026-09-30 |
| K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System | Mui Scientific, Inc. | FFX | Class II | 2026-09-30 |
| K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | QZF | Class II | 2026-09-25 |
| K262353 | BTL-299-F | BTL Industries, Inc. | KPI | Class II | 2026-09-23 |
| K261418 | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | EZD | Class II | 2026-09-23 |
| K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | OWN | Class II | 2026-09-21 |
| K260512 | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | FED | Class II | 2026-09-21 |
| K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | FED | Class II | 2026-09-18 |
| K254179 | Drainage Catheter | Canyon Medical, Inc. | FGE | Class II | 2026-09-18 |
| K262913 | Protégé EverFlex Self-expanding Peripheral Stent System | Medtronic, Inc. | FGE | Class II | 2026-09-17 |
| K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | MSB | Class II | 2026-09-16 |
| K261400 | Ambu® aScope Gastro; Ambu® aScope Gastro Large | Ambu A/S | FDS | Class II | 2026-09-16 |
| K261447 | CVAC® Aspiration System | Calyxo, Inc. | FGB | Class II | 2026-09-15 |
| K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | PKL | Class II | 2026-09-14 |
| K260133 | CADDIE | Odin Medical Limited | QNP | Class II | 2026-09-12 |
| K262397 | CuratOR EX2742 | Eizo Corporation | GCJ | Class II | 2026-09-11 |
| K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FED | Class II | 2026-09-11 |
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | FET | Class II | 2026-09-10 |
| K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | PIF | Class II | 2026-09-10 |
| K254111 | Irrigation/Urology Sets | B.Braun Medical, Inc. | LJH | Class II | 2026-09-10 |
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | Class II | 2026-09-09 |
| K261470 | QF10 | E.A.M Benelux B.V | NHV | Class II | 2026-09-09 |
| K260997 | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | Endoclot Plus Co., Ltd. | PLL | Class II | 2026-09-09 |
| K261823 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | NAY | Class II | 2026-09-08 |
| K262292 | Gastric Alimetry | Alimetry , Ltd. | MYE | Class II | 2026-09-04 |
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | EZL | Class II | 2026-09-04 |
| K260503 | Triton 1 System | Neptune Medical, Inc. | FDF | Class II | 2026-09-03 |
| K262460 | Rezum System | Boston Scientific | KNS | Class II | 2026-09-03 |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | GCJ | Class II | 2026-09-01 |
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | KNW | Class II | 2026-08-28 |
| K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | FDS | Class II | 2026-08-27 |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | FDS | Class II | 2026-08-27 |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | FGB | Class II | 2026-08-26 |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | GCJ | Class II | 2026-08-26 |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB | PIF | Class II | 2026-08-26 |
| K261015 | Solo Scope Colonoscope System | Gi View, Ltd. | FDF | Class II | 2026-08-21 |
| DEN250043 | Qoramatic Automated Stool Management | Cm Technologies, Inc. | SJB | Class II | 2026-08-20 |
| K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | KPO | Class II | 2026-08-19 |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | KNW | Class II | 2026-08-14 |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | FGB | Class II | 2026-08-14 |
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | KNT | Class II | 2026-08-14 |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | GCJ | Class II | 2026-08-13 |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | KNW | Class II | 2026-08-12 |
| K254069 | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2026-08-10 |
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | Nova Eye, Inc. | MPA | Class II | 2026-08-10 |
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | QNP | Class II | 2026-08-07 |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | FDS | Class II | 2026-08-07 |
| K253505 | Zamenix P | Roen Surgical, Inc. | FGB | Class II | 2026-08-07 |
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC | FIE | Class II | 2026-08-06 |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | EZL | Class II | 2026-08-05 |
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | KNY | Class II | 2026-08-05 |
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec | EZD | Class II | 2026-08-05 |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | QNP | Class II | 2026-08-05 |
| K261915 | Navigator Flex Ureteral Access Sheath Set | Boston Scientific Corporation | FED | Class II | 2026-08-04 |
| K260572 | Marrow Marxman | Medimetrix, LLC | KNW | Class II | 2026-08-04 |
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | NAY | Class II | 2026-07-31 |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | ODG | Class II | 2026-07-31 |
| K262200 | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | QNA | Class II | 2026-07-29 |
| K261399 | ELISIO-HX | Nipro Medical Corporation | QAX | Class II | 2026-07-28 |
| K253651 | Revi System | Bluewind Medical , Ltd. | QXM | Class II | 2026-07-28 |
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | FGE | Class II | 2026-07-27 |
| K254180 | PerfusiX-Imaging | LIMIS Development B.V. | OWN | Class II | 2026-07-24 |
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2026-07-24 |
| K262152 | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | FCX | Class II | 2026-07-24 |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | GCJ | Class II | 2026-07-24 |
| K261644 | Perfadex Plus | Xvivo Perfusion AB | KDN | Class II | 2026-07-23 |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | MacroLux Medical Technology Co., Ltd. | FGB | Class II | 2026-07-20 |
| K261573 | ENDOSCOPE HOLDER (182214) | Aktormed GmbH | QZB | Class II | 2026-07-20 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | GCJ | Class II | 2026-07-17 |
| K261658 | LoFric Origo Pro Coudé | Wellspect AB | EZD | Class II | 2026-07-17 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | 2026-07-14 |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. | KNT | Class II | 2026-07-10 |
| K262045 | Luja Soft | Coloplast A.S. | EZD | Class II | 2026-07-07 |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | FDF | Class II | 2026-07-02 |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | FET | Class II | 2026-07-02 |
| K252483 | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | PNR | Class II | 2026-07-01 |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | FET | Class II | 2026-06-24 |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | FGE | Class II | 2026-06-24 |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Hangzhou Jimushi Meditech Co., Ltd. | EZD | Class II | 2026-06-24 |
| K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | QKA | Class II | 2026-06-22 |
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | KPI | Class II | 2026-06-18 |
| K260428 | RIVOS EUS Access Device (M00553900) | Boston Scientific Corporation | ODG | Class II | 2026-06-17 |
| K252933 | DYNE PORT | Dyne Medical Group, Inc. | ODC | Class II | 2026-06-12 |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | GCJ | Class II | 2026-06-11 |
| K260414 | Tech-Image Video Endoscope System | Tech-Image CO., LTD. | GCJ | Class II | 2026-06-10 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | GCJ | Class II | 2026-06-04 |
| K253984 | Instrument Exit Point on Touch Surgery Aide | Covidien, LLC | SFE | Class II | 2026-06-04 |
| K252800 | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | OCZ | Class II | 2026-06-03 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | GCJ | Class II | 2026-06-02 |
| K260456 | VI°Port Liver Preservation System | Traferox Technologies, Inc. | KDN | Class II | 2026-06-01 |
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | FBK | Class II | 2026-05-29 |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. | FCM | Class II | 2026-05-29 |
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | 2026-05-29 |
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | FDF | Class II | 2026-05-28 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | GCJ | Class II | 2026-05-26 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | GCJ | Class II | 2026-05-24 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.