510(k) K122217

CERTUS 140 2.45GHZ ABLATION SYSTEM by Neuwave Medical, Inc. — Product Code NEY

K122217 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "CERTUS 140 2.45GHZ ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 2012. 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.