510(k) K182250

Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) by AngioDynamics, Inc. — Product Code NEY

K182250 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)". The FDA issued a decision of Substantially Equivalent on February 28, 2019. 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.