FDA Product Code FGB: Ureteroscope And Accessories, Flexible/rigid
Ureteroscopy has revolutionized the management of upper urinary tract conditions. FDA product code FGB covers flexible and rigid ureteroscopes and their accessories.
These endoscopic instruments allow urologists to directly access and visualize the ureter and renal pelvis for the diagnosis and treatment of kidney stones, ureteral strictures, and upper tract tumors — without open surgery.
FGB devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Boston Scientific Corporation, Karl Storz SE & CO. KG and STERIS Corporation.
List of Ureteroscope And Accessories, Flexible/rigid devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Ureteroscope And Accessories, Flexible/rigid devices (product code FGB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →