Cardioblate Gemini-s Surgical Ablation Device

Cardioblate Gemini-s Surgical Ablation Device is an FDA 510(k)-cleared medical device (K200514) manufactured by Medtronic. 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 June 2, 2020. Regulation: 8.