GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement— 510(k) K181940

Name: FDA 510(k) clearance K181940
Creator: U.S. Food and Drug Administration
Published: 2018-08-17

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K181940 for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement, Substantially Equivalent on 2018-08-17. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code OXC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2018-07-19
Decision date: 2018-08-17
Decision: Substantially Equivalent
Clearance type: Special
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.