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)
FDA 510(k) clearance K253771 · decided 2026-03-02
Clearance details
- K-number
- K253771
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-26
- Decision date
- 2026-03-02
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- NEY
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Nanjing, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Microwave Ablation Device (K252632) | Nanjing Dewen Medical Technology Co., Ltd. | 2026-03-02 |
| swiftPro System (SWF-SPS); Swift System (SWF-SYS) (K250718) | Emblation Limited | 2025-08-08 |
| Microwave Ablation Generator (KY-2000A, KY-2100A) (K241827) | Canyon Medical, Inc. | 2024-09-26 |
| Microwave Ablation Antennas (K241825) | Canyon Medical, Inc. | 2024-09-20 |
| IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) (K240480) | Varian Medical Systems, Inc. | 2024-07-19 |
| Temperature Sensor Probe (ABL-18TP20) (K240784) | Varian Medical Systems, Inc. | 2024-05-29 |
| swiftPro™ System (K240518) | Emblation Limited | 2024-04-23 |
| Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) (K233838) | Medtronic, Inc. | 2024-03-28 |
| Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) (K233140) | Hygea Medical Technology Co., Ltd. | 2024-01-31 |
| NEUWAVE™ Microwave Ablation System and Accessories (K231738) | Neuwave Medical, Inc. | 2023-11-16 |
| Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (K232241) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
| Microwave Ablation System (BD-GT) (K232240) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
Recalls involving this device
No recalls on record reference this clearance.