510(k) K181153

ICEfx Cryoablation System by Galil Medical, Inc. — Product Code GEH

K181153 is an FDA 510(k) premarket notification submitted by Galil Medical, Inc. for the device "ICEfx Cryoablation System". The FDA issued a decision of Substantially Equivalent on May 15, 2018. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Galil Medical, Inc. has at least 10 other 510(k) clearances on record.