DeviceClearance

Product code OTM— General, Plastic Surgery

AMS MALE TRANSOBTURATOR SLING SYSTEM

Classification name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
12
First cleared
Most recent

FDA classification definition

“surgical treatment of male stress urinary incontinence post-prostatectomy”

— U.S. Food and Drug Administration, device classification record for product code OTM under 21 CFR 878.3300, via openFDA

Market context for product code OTM

FDA has cleared 12 devices under product code OTM between 2006 and 2024, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OTM

Adverse events under product code OTM

product code OTM
Injury
760
Total
760

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OTM

Data sourced from openFDA. This site is unofficial and independent of the FDA.