510(k) K963970

ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM by Endocare, Inc. — Product Code GEH

K963970 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 25, 1997. 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.