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 Ambu A/S, KARL STORZ Endoscopy-America, Inc. and Olympus Medical Systems Corporation.
List of Cystoscope And Accessories, Flexible/rigid devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Cystoscope And Accessories, Flexible/rigid devices (product code FAJ). 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 →