swiftPro™ System
510(k) K240518
swiftPro System is a medical device (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Emblation Limited, cleared under FDA 510(k) K240518 on 23 Apr 2024, active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240518 | Date23 Apr 2024 | StatusActive |
Official records
- FDA 510(k) database K240518
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NEY
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K240518
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| swiftPro Battery Pack SWF-BAT01 | SWF-BAT01 / SWF-BAT01 | 05060652910138 | — | On the market |
| swiftPro Battery Power System SWF-BPS01 | SWF-BPS01 / SWF-BPS01 | 05060652910152 | — | On the market |
| swiftPro Charging Dock DC Power Adaptor SWF-DCA02 | SWF-DCA02 / SWF-DCA02 | 05060652910176 | — | On the market |
| swiftPro Charging Dock SWF-CHG01 | SWF-CHG01 / SWF-CHG01 | 05060652910145 | — | On the market |
| swiftPro System SWF-SPS01 | SWF-SPS01 / SWF-SPS01 | 05060652910213 | — | On the market |
Similar devices
Other devices filed under FDA product code NEY (System, Ablation, Microwave And Accessories).
- Certus 140 2.45GHz Ablation System by NeuWave Medical, Inc.
- Emprint SX Ablation Platform and Accessories by Coviden, LLC
- Disposable Microwave Therapeutic Antennas by Nanjing Eco Microwave System Co., Ltd.
- FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM by Afx, Inc.
- Avecure 16-10-LH-15 by Medwaves Incorporated
- MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX by Bsd Medical Corp.
- Emprint CAPUMP1 by Covidien LP
- MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM by Medwaves Incorporated
- ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR by Microsulis Medical, Ltd.
- Emprint CA30L2 by Covidien LP