GORE® ENFORM Biomaterial— 510(k) K222919

Name: FDA 510(k) clearance K222919
Creator: U.S. Food and Drug Administration
Published: 2022-12-19

Substantially Equivalent

W. L. Gore and Associates, Inc.

FDA 510(k) clearance K222919 for GORE® ENFORM Biomaterial, Substantially Equivalent on 2022-12-19. Applicant: W. L. Gore and Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore and Associates, Inc.
Product code: Code OXF
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2022-09-26
Decision date: 2022-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.