510(k) K021010

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE by Endocare, Inc. — Product Code OCL

K021010 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Endocare, Inc. has at least 10 other 510(k) clearances on record.