GORE BIOABSORBABLE MESH— 510(k) K033671

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K033671 for GORE BIOABSORBABLE MESH, Substantially Equivalent on 2003-12-31. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code OWT
Advisory panel: General, Plastic Surgery
Date received: 2003-11-24
Decision date: 2003-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code OWT

product code OWT

Death: 3
Injury: 396
Total: 399

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.