DeviceClearance

Product code OTN— General, Plastic Surgery

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Classification name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
65
First cleared
Most recent

FDA classification definition

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

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

Market context for product code OTN

FDA has cleared 65 devices under product code OTN between 1996 and 2023, filed by 28 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

last 15 years

Top applicants under product code OTN

Adverse events under product code OTN

product code OTN
Injury
6,630
Total
6,630

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 OTN

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