GORE-TEX SURGICAL TAPE— 510(k) K894580

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K894580 for GORE-TEX SURGICAL TAPE, Substantially Equivalent on 1989-10-10. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 1989-07-24
Decision date: 1989-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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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.