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:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 153d |
| All-time average (cleared) | 130d |
| Not Substantially Equivalent (denied) | 292d |
Recent Gastroenterology & Urology submissions have taken longer than the historical average - 153 days in the last 2 years vs 130 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 292 days before receiving a Not Substantially Equivalent determination.
This page lists all 9843 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.
This page lists 9843 medical devices in the Gastroenterology & Urology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 9796 were cleared as substantially equivalent to a predicate device. Average FDA review time: 130 days. Records from 1976 to the present.
You can use this list to:
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.
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