OneRF Trigeminal Nerve Radiofrequency Probes— 510(k) K251243
Substantially EquivalentNeuroone Medical Technologies Corp.
FDA 510(k) clearance K251243 for OneRF Trigeminal Nerve Radiofrequency Probes, Substantially Equivalent on 2025-08-15. Applicant: Neuroone Medical Technologies Corp..
Clearance details
- Applicant
- Neuroone Medical Technologies Corp.
- Product code
- Code GXI
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.