FDA Product Code FAJ: Cystoscope And Accessories, Flexible/rigid

Direct visualization of the bladder is essential for the diagnosis and treatment of urological conditions. FDA product code FAJ covers flexible and rigid cystoscopes and their accessories.

These endoscopes allow urologists to directly inspect the bladder mucosa, ureteral orifices, and urethra for the diagnosis of bladder cancer, hematuria, and infection, and for therapeutic procedures including biopsy and stone removal.

FAJ 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., Uroviu Corporation and Ambu A/S.