Emprint SX Ablation Platform with Thermosphere Technology

Emprint SX Ablation Platform with Thermosphere Technology is an FDA 510(k)-cleared medical device (K203303) 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 December 16, 2020. Regulation: 8.