ICEROD CX CRYOABLATION NEEDLE

ICEROD CX CRYOABLATION NEEDLE is an FDA 510(k)-cleared medical device (K140584) manufactured by Galil Medical , Ltd.. 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 March 30, 2014. Regulation: 8.