510(k) Gastroenterology & Urology Devices

FDA 510(k) Cleared Gastroenterology & Urology Devices

This page lists all 9793 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.

• 9747 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 130 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.