OTM

Mesh, Surgical, For Stress Urinary Incontinence, Male

Product code

OTM

Device name

Mesh, Surgical, For Stress Urinary Incontinence, Male

Device class

Class 2

21 CFR

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

surgical treatment of male stress urinary incontinence post-prostatectomy

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-11-15.

2 summaries are archived here for direct download.