HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE

HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE is an FDA 510(k)-cleared medical device (K002021) manufactured by Gyrus Ent 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 August 23, 2000. Regulation: 8.