K250522
- 510(k) number
- K250522
- Device name
- Multi4 System
- Applicant
- Multi4 Medical AB SE
- Product code
- FAS — Electrode, Electrosurgical, Active, Urological
- Decision date
- 2025-06-27
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250522.pdf
Official FDA record: K250522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.