About This 510(k) Submission
K253771 is an FDA 510(k) clearance for the Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13), a System, Ablation, Microwave And Accessories (Class II — Special Controls, product code NEY), submitted by Nanjing Devin Medical Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 2, 2026, 96 days after receiving the submission on November 26, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.