510(k) K203032

IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle by Galil Medical, Inc. — Product Code GEH

K203032 is an FDA 510(k) premarket notification submitted by Galil Medical, Inc. for the device "IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle". The FDA issued a decision of Substantially Equivalent on November 2, 2020. 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.