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 Uroviu Corporation, Guangzhou Red Pine Medical Instrument Co., Ltd. and Ambu A/S.
FDA 510(k) Cleared Cystoscope And Accessories, Flexible/rigid Devices (Product Code FAJ)
About Product Code FAJ - Regulatory Context
510(k) Submission Activity
90 total 510(k) submissions under product code FAJ since 1976, with 90 receiving FDA clearance (average review time: 128 days).
Submission volume has increased in recent years - 20 submissions in the last 24 months compared to 9 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for FAJ submissions have been consistent, averaging 127 days recently vs 128 days historically.
FAJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →