AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1

AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 is an FDA 510(k)-cleared medical device (K101057) manufactured by Salient Surgical Technologies. 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 April 4, 2011. Regulation: 8.