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 Hunan Vathin Medical Instrument Co., Ltd., Boston Scientific Corporation and Karl Storz SE & CO. KG.
FDA 510(k) Cleared Ureteroscope And Accessories, Flexible/rigid Devices (Product Code FGB)
About Product Code FGB - Regulatory Context
510(k) Submission Activity
113 total 510(k) submissions under product code FGB since 1981, with 113 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 31 submissions in the last 24 months compared to 14 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FGB have taken an average of 150 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.
FGB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →