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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 · Compiled by Zalwin from U.S. FDA openFDA

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)

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.

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Records
27
Most frequent
  1. Ovesco Endoscopy AG (2)
  2. CapsoVision, Inc. (1)
  3. Canyon Medical, Inc. (1)
  4. Poly Medicure Limited (1)
  5. Vein 360 (1)

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What are the top FDA 510(k) clearances and recalls: Gastroenterology & Urology devices right now?

RecordSpecialtyTypeDate
CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.Gastroenterology, Urology510(k)2026-09-25
Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.Gastroenterology, Urology510(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 AGGastroenterology, Urology510(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, SinGastroenterology, Urology510(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 360Gastroenterology, Urology510(k)2026-10-20
multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLCGastroenterology, Urology510(k)2026-10-19
OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.Gastroenterology, Urology510(k)2026-10-06
stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AGGastroenterology, Urology510(k)2026-10-02
Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.Gastroenterology, Urology510(k)2026-09-21
CADDIE (K260133): 510(k) cleared for Odin Medical LimitedGastroenterology, Urology510(k)2026-09-12
Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd.Gastroenterology, Urology510(k)2026-09-11
Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.Gastroenterology, Urology510(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, Urology510(k)2026-10-14
Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical)Gastroenterology, Urology510(k)2026-10-14
Plenity-V (MC0979 / GS110) (K261783): 510(k) cleared for Gelesis SRLGastroenterology, Urology510(k)2026-10-02
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris 🔒 Unlock all 27 records →
Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd. 🔒 Unlock all 27 records →
danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH 🔒 Unlock all 27 records →
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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

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

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