510(k) K082203

NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 by Ncontact Surgical, Inc. — Product Code OCL

K082203 is an FDA 510(k) premarket notification submitted by Ncontact Surgical, Inc. for the device "NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025". The FDA issued a decision of Substantially Equivalent on December 30, 2008. 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.