510(k) K253771 ยท NEY System, Ablation, Microwave And Accessories
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)
| Applicant | Nanjing Devin Medical Technology Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Mar 2, 2026 |
| Received | Nov 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253771
No recall in the FDA data names this 510(k).
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