ECHELON GRAY CARTRIDGE, MODEL ERC45M

ECHELON GRAY CARTRIDGE, MODEL ERC45M is an FDA 510(k)-cleared medical device (K080839) 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 May 20, 2008. Regulation: 8.