510(k) K162599

IcePearl 2.1 CX L, IceForce 2.1 CX L by Galil Medical , Ltd. — Product Code GEH

K162599 is an FDA 510(k) premarket notification submitted by Galil Medical , Ltd. for the device "IcePearl 2.1 CX L, IceForce 2.1 CX L". The FDA issued a decision of Substantially Equivalent on October 11, 2016. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Galil Medical , Ltd. has at least 10 other 510(k) clearances on record.