510(k) K023757

CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 by Endocare, Inc. — Product Code GEH

K023757 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20". The FDA issued a decision of Substantially Equivalent on December 5, 2002. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Endocare, Inc. has at least 10 other 510(k) clearances on record.