510(k) K200061

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) by Galil Medical, Inc. — Product Code NEY

K200061 is an FDA 510(k) premarket notification submitted by Galil Medical, Inc. for the device "HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)". The FDA issued a decision of Substantially Equivalent on July 9, 2020. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Galil Medical, Inc. has at least 10 other 510(k) clearances on record.