AMS LARGE PORE POLYPROPHLENE MESH— 510(k) K121805

Substantially Equivalent

American Medical Systems

FDA 510(k) clearance K121805 for AMS LARGE PORE POLYPROPHLENE MESH, Substantially Equivalent on 2012-10-16. Applicant: American Medical Systems.

Clearance details

Applicant: American Medical Systems
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2012-06-19
Decision date: 2012-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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