510(k) K250718
K250718 is an FDA 510(k) premarket notification submitted by Emblation Limited for the device "swiftPro System (SWF-SPS); Swift System (SWF-SYS)". The FDA issued a decision of Substantially Equivalent on August 8, 2025. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Emblation Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2025
- Date Received
- March 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type