COROLENE— 510(k) K052701

Substantially Equivalent

Peters Surgical

FDA 510(k) clearance K052701 for COROLENE, Substantially Equivalent on 2005-12-13. Applicant: Peters Surgical.

Clearance details

Applicant: Peters Surgical
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 2005-09-28
Decision date: 2005-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bobigny, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.