RESTORELLE L— 510(k) K122440

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K122440 for RESTORELLE L, Substantially Equivalent on 2012-11-19. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2012-08-10
Decision date: 2012-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
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.