510(k) K252632

Microwave Ablation Device by Nanjing Dewen Medical Technology Co., Ltd. — Product Code NEY

K252632 is an FDA 510(k) premarket notification submitted by Nanjing Dewen Medical Technology Co., Ltd. for the device "Microwave Ablation Device". The FDA issued a decision of Substantially Equivalent on March 2, 2026. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400.