Echelon Endopath Staple Line Reinforcement

Echelon Endopath Staple Line Reinforcement is an FDA 510(k)-cleared medical device (K190937) manufactured by Ethicon Endo-Surgery, LLC. 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 October 13, 2019. Regulation: 8.