RESTORELLE Y CONTOUR MESH— 510(k) K140116

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K140116 for RESTORELLE Y CONTOUR MESH, Substantially Equivalent on 2014-02-12. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2014-01-16
Decision date: 2014-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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.