K251317
- 510(k) number
- K251317
- Device name
- SOLOPASS 2.0 System
- Applicant
- Intravent Medical Partners PA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-09-05
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K251317.pdf
Official FDA record: K251317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.