K240518
- 510(k) number
- K240518
- Device name
- swiftPro System
- Applicant
- Emblation Limited GB
- Product code
- NEY — System, Ablation, Microwave And Accessories
- Decision date
- 2024-04-23
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240518.pdf
Official FDA record: K240518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.