RESTORELLE M, RESTORELLE XL— 510(k) K132061

Name: FDA 510(k) clearance K132061
Creator: U.S. Food and Drug Administration
Published: 2013-08-02

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K132061 for RESTORELLE M, RESTORELLE XL, Substantially Equivalent on 2013-08-02. Applicant: Coloplast Corp.. Device class: 2.

Clearance details

Applicant: Coloplast Corp.
Product code: Code OTO
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-07-03
Decision date: 2013-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.