Clearance Summary
OneRF Ablation System received FDA 510(k) clearance under submission number K231675, sponsored by Neuroone Medical Technologies Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-12-06.
- Submission: K231675
- Applicant / Sponsor: Neuroone Medical Technologies Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4400
- Decision date: 2023-12-06
Classification & Regulation
This clearance is catalogued under FDA product code GXD and 21 CFR 882.4400, within the Neurology review panel as a Class II device.