MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM

MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM is an FDA 510(k)-cleared medical device (K091107) manufactured by Hemostatix Medical Technologies, 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 April 30, 2009. Regulation: 8.