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..
FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Devices (Product Code OTN)
About Product Code OTN - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code OTN since 1996, with 65 receiving FDA clearance (average review time: 82 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
OTN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →