SURGICAL APPAREL— 510(k) K914832

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K914832 for SURGICAL APPAREL, Substantially Equivalent on 1992-02-14. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1991-10-25
Decision date: 1992-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.