510(k) K100744

CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 by Neuwave Medical, Inc. — Product Code NEY

K100744 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140". The FDA issued a decision of Substantially Equivalent on October 22, 2010. 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.