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.
FDA 510(k) Cleared Stent, Ureteral Devices (Product Code FAD)
About Product Code FAD - Regulatory Context
510(k) Submission Activity
122 total 510(k) submissions under product code FAD since 1978, with 122 receiving FDA clearance (average review time: 154 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FAD have taken an average of 182 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
FAD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →