
Ethicon Endo-Surgery, LLC
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ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL is an FDA 510(k)-cleared medical device (K112056) 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 December 18, 2011. Regulation: 8.