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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 the device name listed in this FDA 510(k) record. The listed applicant is Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) 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. The listed applicant is Neuroone Medical Technologies Corp.. The 510(k) number is K251243.

When did OneRF Trigeminal Nerve Radiofrequency Probes receive FDA 510(k) clearance?

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

Who is the listed applicant for OneRF Trigeminal Nerve Radiofrequency Probes?

The FDA 510(k) record lists Neuroone Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Neuroone Medical Technologies Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231675OneRF Ablation SystemK222404Evo® sEEG SystemK211367Evo sEEG System

Related Devices (Code: GXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.

Official Source

View on FDA Database →

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

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