OTN

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Product code

OTN

Device name

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Device class

Class 2

21 CFR

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

65 (all years; only the last 3 years are listed here)

FDA classification definition

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Definition text from the FDA device classification database (U.S. federal government work, public domain).