REPROCESSED HAND ACTIVATE SEALER/DIVIDER

REPROCESSED HAND ACTIVATE SEALER/DIVIDER is an FDA 510(k)-cleared medical device (K111600) manufactured by Ascent Healthcare Solutions. 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 November 14, 2011. Regulation: 8.