swiftPro System SWF-MIC01
swiftPro System SWF-MIC01 is a microwave hyperthermia system (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Emblation Limited, cleared under FDA 510(k) K222388 on 4 May 2023 and listed in FDA GUDID since 4 Dec 2023 (UDI-DI 05060652910053), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060652910053 | Date4 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222388 | Date4 May 2023 | StatusActive |
Official records
- AccessGUDID record 05060652910053
- FDA 510(k) database K222388
Across registries
- FDA 510(k) K222388 decided 4 May 2023 Active
- FDA GUDID UDI-DI 05060652910053 listed 4 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K222388
- Listed FDA GUDID 05060652910053
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- swiftPro System
- Generic name
- Microwave hyperthermia system
- Model / Ref / Catalog
- SWF-MIC01
- Primary DI / UDI-DI
- 05060652910053
- FDA product code
- NEY
- GMDN term
- Microwave hyperthermia system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution