510(k) K053535

VIVAWAVE MICROWAVE ABLATION SYSTEM by Valleylab — Product Code NEY

K053535 is an FDA 510(k) premarket notification submitted by Valleylab for the device "VIVAWAVE MICROWAVE ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 27, 2006. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Valleylab has at least 10 other 510(k) clearances on record.