510(k) K163118

FLEX Microwave Ablation System and Accessories by Neuwave Medical, Inc. — Product Code NEY

K163118 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "FLEX Microwave Ablation System and Accessories". The FDA issued a decision of Substantially Equivalent on March 9, 2017. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Neuwave Medical, Inc. has at least 10 other 510(k) clearances on record.