- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Gastroenterology & Urology # FDA 510(k) clearances and recalls: Gastroenterology & Urology devices **27 FDA 510(k) clearances and recalls: Gastroenterology & Urology devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Ovesco Endoscopy AG with 2. Data last updated 2026-11-04; each record links to its official source and a full report.** Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 27 FDA 510(k) clearances and recalls: Gastroenterology & Urology devices (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Gastroenterology%2C%20Urology) 27 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Ovesco Endoscopy AG (2). Each record links to a full report and the official source. Last updated 2026-11-04. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Gastroenterology%2C%20Urology&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Gastroenterology%2C%20Urology) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 27 Most frequent - Ovesco Endoscopy AG (2) - CapsoVision, Inc. (1) - Canyon Medical, Inc. (1) - Poly Medicure Limited (1) - Vein 360 (1) ## How do I get new FDA 510(k) clearances and recalls: Gastroenterology & Urology devices by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Gastroenterology%2C%20Urology) [Watch this exact filter](/v/fdapulse?panel=Gastroenterology%2C%20Urology#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top FDA 510(k) clearances and recalls: Gastroenterology & Urology devices right now? | Record | Specialty | Type | Date | |---|---|---|---| | CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-25 | | Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-18 | | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG | Gastroenterology, Urology | 510(k) | 2026-09-14 | | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin | Gastroenterology, Urology | 510(k) | 2026-10-23 | | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360 | Gastroenterology, Urology | 510(k) | 2026-10-20 | | multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | 510(k) | 2026-10-19 | | OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc. | Gastroenterology, Urology | 510(k) | 2026-10-06 | | stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG | Gastroenterology, Urology | 510(k) | 2026-10-02 | | Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Gastroenterology, Urology | 510(k) | 2026-09-21 | | CADDIE (K260133): 510(k) cleared for Odin Medical Limited | Gastroenterology, Urology | 510(k) | 2026-09-12 | | Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. | Gastroenterology, Urology | 510(k) | 2026-09-11 | | Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-30 | | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. | Gastroenterology, Urology | 510(k) | 2026-10-14 | | Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical) | Gastroenterology, Urology | 510(k) | 2026-10-14 | | Plenity-V (MC0979 / GS110) (K261783): 510(k) cleared for Gelesis SRL | Gastroenterology, Urology | 510(k) | 2026-10-02 | | MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris | Included in the full CSV with every column 🔒 Unlock all 27 records → | | Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 27 records → | | danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH | Included in the full CSV with every column 🔒 Unlock all 27 records → | Browse 12 more matching record reports - [MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris](/report/fdapulse/medivators-advantage-nxt-automated-endoscope-reprocessor-oh--k261791) - [Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd.](/report/fdapulse/hemostatic-clip-k261741-cn--k261741) - [danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH](/report/fdapulse/danumed-stomameter-k262038-de--k262038) - [BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc.](/report/fdapulse/btl-299-f-k262353-ma--k262353) - [Liquick X-treme, Liquick X-treme Plus (K261418): 510(k) cleared for Teleflex Medical](/report/fdapulse/liquick-x-treme-liquick-x-treme-plus-k261418-ie--k261418) - [KARL STORZ TIPCAM1 Rubina (K262547): 510(k) cleared for KALR STORZ SE & Co. KG](/report/fdapulse/karl-storz-tipcam1-rubina-k262547-de--k262547) - [Protégé™ EverFlex™ Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc.](/report/fdapulse/protege-everflex-self-expanding-peripheral-stent-system-mn--k262913) - [Pathfinder Endoscope Overtube (K262262): 510(k) cleared for Neptune Medical, Inc.](/report/fdapulse/pathfinder-endoscope-overtube-k262262-ca--k262262) - [X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc.](/report/fdapulse/x-port-heart-preservation-system-k261913-ca--k261913) - [Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (K261400): 510(k) cleared for Ambu A/S](/report/fdapulse/ambu-ascope-gastro-ambu-ascope-gastro-large-k261400-dk--k261400) - [CVAC® Aspiration System (K261447): 510(k) cleared for Calyxo, Inc.](/report/fdapulse/cvac-aspiration-system-k261447-ca--k261447) - [CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation](/report/fdapulse/curator-ex2742-k262397-jp--k262397) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many FDA 510(k) clearances and recalls: Gastroenterology & Urology devices are listed? 27 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for Gastroenterology & Urology? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.