K250795
- 510(k) number
- K250795
- Device name
- PUREVUE FMS
- Applicant
- W.O.M. World of Medicine GmbH DE
- Product code
- HRX — Arthroscope
- Decision date
- 2025-12-05
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250795.pdf
Official FDA record: K250795
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.