FDA Product Code OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
FDA product code OTN covers synthetic urogynecological mesh used for the surgical treatment of female stress urinary incontinence.
These synthetic polypropylene mesh tapes are placed under the mid-urethra through a minimally invasive approach to provide a supportive hammock that prevents urinary leakage during physical activity. Midurethral slings have become the standard surgical treatment for stress urinary incontinence.
OTN devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Boston Scientific Corporation and Caldera Medical, Inc..
List of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator devices (product code OTN). 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 →