GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES— 510(k) K010228

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K010228 for GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES, Substantially Equivalent on 2001-02-21. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2001-01-24
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, 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.