PERMACOL SURGICAL IMPLANT— 510(k) K120605

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K120605 for PERMACOL SURGICAL IMPLANT, Substantially Equivalent on 2012-05-18. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2012-02-28
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.