PERMACOL SURGICAL IMPLANT— 510(k) K043366

Substantially Equivalent

Tissue Science Laboratories, Plc

FDA 510(k) clearance K043366 for PERMACOL SURGICAL IMPLANT, Substantially Equivalent on 2004-12-17. Applicant: Tissue Science Laboratories, Plc.

Clearance details

Applicant: Tissue Science Laboratories, Plc
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2004-12-08
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.