K252594
- 510(k) number
- K252594
- Device name
- UltraGuideCTR® image guided soft tissue release system
- Applicant
- Sonex Health MN · US
- Product code
- HRX — Arthroscope
- Decision date
- 2025-09-29
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252594.pdf
Official FDA record: K252594
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.