MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is an FDA 510(k)-cleared medical device (K233185) manufactured by C2dx, Inc.. 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 October 23, 2023. Regulation: 8.