510(k) K223581

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

K223581 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 March 27, 2023. 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.