510(k) K141485

ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE by Galil Medical , Ltd. — Product Code GEH

K141485 is an FDA 510(k) premarket notification submitted by Galil Medical , Ltd. for the device "ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE". The FDA issued a decision of Substantially Equivalent on July 2, 2014. 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.