510(k) K121858

THE ABLATION SYSTEM by Halt Medical, Inc. — Product Code HFG

K121858 is an FDA 510(k) premarket notification submitted by Halt Medical, Inc. for the device "THE ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2012. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Halt Medical, Inc. has at least 3 other 510(k) clearances on record.