510(k) K251317 ยท HAW Neurological Stereotaxic Instrument
SOLOPASS 2.0 System
| Applicant | Intravent Medical Partners, Blue Bell PA, US |
| Decision | Substantially Equivalent, Sep 5, 2025 |
| Received | Apr 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251317
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.