FDA Product Code FAD: Stent, Ureteral

Under FDA product code FAD, ureteral stents are cleared for maintaining ureteral patency in patients with obstruction or following urological procedures.

These flexible double-J or double-pigtail devices are placed endoscopically to bridge a ureteral obstruction or hold the ureter open after stone treatment, surgery, or trauma. They allow urine to flow from the kidney to the bladder while the underlying condition is treated.

FAD devices are Class II medical devices, regulated under 21 CFR 876.4620 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Boston Scientific Corporation, Coloplast Corp. and Ureteral Stent Company.