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 and Coloplast Corp..
List of Stent, Ureteral devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stent, Ureteral devices (product code FAD). 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 →