510(k) K232635

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) by Boston Scientific — Product Code GEH

K232635 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)". The FDA issued a decision of Substantially Equivalent on November 22, 2023. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Boston Scientific has at least 10 other 510(k) clearances on record.