ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is an FDA 510(k)-cleared medical device (K213633) manufactured by Ethicon Endo-Surgery, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 7, 2022. Regulation: 8.