FDA 510(k)

OneRF Trigeminal Nerve Radiofrequency Probes

K-Number: K251243 · 2025-08-15

ApplicantNeuroone Medical Technologies Corp.

Decision Date2025-08-15

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OneRF Trigeminal Nerve Radiofrequency Probes is a medical device manufactured by Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2025-08-15 under approval number K251243. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OneRF Trigeminal Nerve Radiofrequency Probes?

OneRF Trigeminal Nerve Radiofrequency Probes is a medical device that received FDA 510(k) clearance on 2025-08-15. It is manufactured by Neuroone Medical Technologies Corp.. The 510(k) number is K251243.

When was OneRF Trigeminal Nerve Radiofrequency Probes approved by the FDA?

OneRF Trigeminal Nerve Radiofrequency Probes received FDA 510(k) clearance on 2025-08-15, under approval number K251243.

What company makes OneRF Trigeminal Nerve Radiofrequency Probes?

OneRF Trigeminal Nerve Radiofrequency Probes is manufactured by Neuroone Medical Technologies Corp..

What is the FDA product code for OneRF Trigeminal Nerve Radiofrequency Probes?

The FDA product code for OneRF Trigeminal Nerve Radiofrequency Probes is GXI.

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Other Devices by Neuroone Medical Technologies Corp.

K211367Evo sEEG System K222404Evo® sEEG System K231675OneRF Ablation System

Related Devices (Code: GXI)

K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. K152642LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeLccs Products Limited K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems K170708OWL RF INSULATED CANNULAEDiros Technology, Inc. K163461Coolief* Cooled RF ProbeHalyard Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.