K250718 is an FDA 510(k) clearance for the swiftPro System (SWF-SPS); Swift System (SWF-SYS), a System, Ablation, Microwave And Accessories (Class II — Special Controls, product code NEY), submitted by Emblation Limited (Stirling, GB). The FDA issued a Cleared decision on August 8, 2025, 151 days after receiving the submission on March 10, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K250718 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 2025 |
| Decision Date | August 08, 2025 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEY — System, Ablation, Microwave And Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |