BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is an FDA 510(k)-cleared medical device (K193356) manufactured by Covidien, LLC. 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 March 1, 2020. Regulation: 8.