510(k) K200081

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

K200081 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "NEUWAVE Microwave Ablation System and Accessories". The FDA issued a decision of Substantially Equivalent on November 13, 2020. 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.