510(k) K251243 ยท GXI Probe, Radiofrequency Lesion
OneRF Trigeminal Nerve Radiofrequency Probes
| Applicant | Neuroone Medical Technologies Corp., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Aug 15, 2025 |
| Received | Apr 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251243
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.