510(k) K201588

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice by Varian Medical Systems, Inc. — Product Code GEH

K201588 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice". The FDA issued a decision of Substantially Equivalent on Aug 11, 2020. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Varian Medical Systems, Inc. has 205 other 510(k) clearances on record.