ENSEAL X1 Large Jaw Tissue Sealer

ENSEAL X1 Large Jaw Tissue Sealer is an FDA 510(k)-cleared medical device (K163548) 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 February 13, 2017. Regulation: 8.