FDA 510(k) Gastroenterology & Urology Devices
About Gastroenterology & Urology Devices
FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.
Common device types:
- GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
- Biliary and pancreatic stents - metal and plastic biliary drainage devices
- Urological devices - ureteral stents, catheters, stone retrieval baskets
- Ablation systems - RFA and cryoablation for GI lesions
- Anorectal devices - manometry systems, hemorrhoid treatment
FDA 510(k) Cleared Gastroenterology & Urology Devices
This page lists all 258 medical devices in the Gastroenterology & Urology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Endoscopes, stents, urology devices and gastrointestinal diagnostic tools.
- 256 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 152 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 258 medical devices in the Gastroenterology & Urology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 256 were cleared as substantially equivalent to a predicate device. Average FDA review time: 152 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to gastroenterology & urology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices