
Ethicon Endo-Surgery, Inc.
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ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH is an FDA 510(k)-cleared medical device (K101520) manufactured by Ethicon Endo-Surgery, Inc.. 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 9, 2010. Regulation: 8.