510(k) K251928

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) by Medinice S.A. — Product Code GEH

K251928 is an FDA 510(k) premarket notification submitted by Medinice S.A. for the device "CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.