ENSEAL PTC TISSUE SEATING SEALING DEVICE

ENSEAL PTC TISSUE SEATING SEALING DEVICE is an FDA 510(k)-cleared medical device (K062949) manufactured by Surgrx, 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 October 17, 2006. Regulation: 8.