510(k) K071819

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 by Ncontact Surgical, Inc. — Product Code OCL

K071819 is an FDA 510(k) premarket notification submitted by Ncontact Surgical, Inc. for the device "NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515". The FDA issued a decision of Substantially Equivalent on July 26, 2007. 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. Ncontact Surgical, Inc. has at least 6 other 510(k) clearances on record.