PlumeSafe X5 Smoke Management System

PlumeSafe X5 Smoke Management System is an FDA 510(k)-cleared medical device (K240127) manufactured by Conmed Corporation. 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 4, 2024. Regulation: 8.