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 KARL STORZ Endoscopy-America, Inc., Shanghai AnQing Medical Instrument Co., Ltd. and Hunan Vathin Medical Instrument Co., Ltd..