ECHELON ENDOPATH Staple Line Reinforcement

ECHELON ENDOPATH Staple Line Reinforcement is an FDA 510(k)-cleared medical device (K221343) 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 September 15, 2022. Regulation: 8.