NEY
- Product code
- NEY
- Device name
- System, Ablation, Microwave And Accessories
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 13
- Summaries archived here
- 12 (direct download)
- 510(k) clearances (all years, FDA)
- 68 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252632 | 2026-03-02 | Nanjing Dewen Medical Technology Co., … | Microwave Ablation Device | |
| K253771 | 2026-03-02 | Nanjing Devin Medical Technology Co., … | Disposable Microwave Ablation Antenna (DW-XR-II1, DW… | |
| K250718 | 2025-08-08 | Emblation Limited | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | |
| K241827 | 2024-09-26 | Canyon Medical, Inc. | Microwave Ablation Generator (KY-2000A, KY-2100A) | |
| K241825 | 2024-09-20 | Canyon Medical, Inc. | Microwave Ablation Antennas | |
| K240480 | 2024-07-19 | Varian Medical Systems, Inc. | IntelliBlate Microwave Ablation System Console (IB-C… | |
| K240784 | 2024-05-29 | Varian Medical Systems, Inc. | Temperature Sensor Probe (ABL-18TP20) | |
| K240518 | 2024-04-23 | Emblation Limited | swiftPro System | |
| K233838 | 2024-03-28 | Medtronic, Inc. | Emprint Ablation System with Thermosphere Technology… | FDA |
| K233140 | 2024-01-31 | Hygea Medical Technology Co., Ltd. | Microwave Ablation Device (Exceed S10U); Sterile Mic… | |
| K231738 | 2023-11-16 | Neuwave Medical, Inc. | NEUWAVE Microwave Ablation System and Accessories | |
| K232240 | 2023-11-13 | Betters(Suzhou) Medical Co., Ltd. | Microwave Ablation System (BD-GT) | |
| K232241 | 2023-11-13 | Betters(Suzhou) Medical Co., Ltd. | Disposable Microwave Ablation Needle (T-1408, T-1410… |
Official FDA classification page: NEY
Classification and pathway per current FDA publications. Data from openFDA (CC0).