GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is an FDA 510(k)-cleared medical device (K181940) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 2018. Regulation: 8.