BiZact Open Sealer/Divider

BiZact Open Sealer/Divider is an FDA 510(k)-cleared medical device (K160539) manufactured by Covidien. 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 June 14, 2016. Regulation: 8.