AtriCure cryoICE cryoSPHERE cryoablation probe

AtriCure cryoICE cryoSPHERE cryoablation probe is an FDA 510(k)-cleared medical device (K182565) manufactured by AtriCure, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2018. Regulation: 8.