K251243
- 510(k) number
- K251243
- Device name
- OneRF Trigeminal Nerve Radiofrequency Probes
- Applicant
- Neuroone Medical Technologies Corp. MN · US
- Product code
- GXI — Probe, Radiofrequency Lesion
- Decision date
- 2025-08-15
- Date received
- 2025-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K251243.pdf
Official FDA record: K251243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.