510(k) K213067

Solero Microwave Tissue Ablation (MTA) System and Accessories by AngioDynamics, Inc. — Product Code NEY

K213067 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "Solero Microwave Tissue Ablation (MTA) System and Accessories". The FDA issued a decision of Substantially Equivalent on December 3, 2021. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. AngioDynamics, Inc. has at least 10 other 510(k) clearances on record.