Microwave Ablation Device— 510(k) K252632
Substantially EquivalentNanjing Dewen Medical Technology Co., Ltd.
FDA 510(k) clearance K252632 for Microwave Ablation Device, Substantially Equivalent on 2026-03-02. Applicant: Nanjing Dewen Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nanjing Dewen Medical Technology Co., Ltd.
- Product code
- Code NEY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code NEY
view all- K253771 — 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)
- K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241825 — Microwave Ablation Antennas
- K240480 — IntelliBlate Microwave Ablation System Console (IB-CON) +4 more
Adverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.