GORE BIO-A Tissue Reinforcement— 510(k) K191773

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K191773 for GORE BIO-A Tissue Reinforcement, Substantially Equivalent on 2019-07-31. 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: 2019-07-02
Decision date: 2019-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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.