OneRF Trigeminal Nerve Radiofrequency Probes

Q: What is the product code of K251243?

The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.

FDA 510(k) K251243 · Neuroone Medical Technologies Corp.

Substantially Equivalent

510(k) numberK251243

Submission

Device name: OneRF Trigeminal Nerve Radiofrequency Probes
Applicant: Neuroone Medical Technologies Corp.
Eden Prairie, MN, US
Received: April 22, 2025
Decision date: August 15, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXI – Probe, Radiofrequency Lesion
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4725
Specialty: Neurology

Other 510(k)s with product code GXI

510(k)	Device	Applicant	Decision
K253907	Disposable Radiofrequency CannulaGXI · Traditional	Abbott Medical	04/16/2026SE
K251802	STAR RF Ablation SystemGXI · Traditional	Merit Medical Systems, Inc.	02/13/2026SE
K242841	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI · Traditional	Abbott Medical	05/27/2025SE
K250213	OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional	Stryker Instruments	05/15/2025SE
K241367	RF CannulaGXI · Traditional	Shanghai Samedical & Plastic Instruments Co., Ltd.	01/23/2025SE
K222281	Intracept Intraosseous Nerve Ablation SystemGXI · Traditional	Relievant Medsystems, Inc.	10/26/2022SE
K213836	Intracept Intraosseous Nerve Ablation SystemGXI · Traditional	Relievant Medsystems, Inc.	03/11/2022SE
K203066	COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional	Avanos Medical, Inc.	12/22/2020SE
K190259	Vesta RF CannulaGXI · Special	Biomerics	02/07/2020SE
K191293	LCCS VC-S RF CannulaGXI · Traditional	Lccs Products Limited	01/24/2020SE

More from Lccs Products Limited

510(k)	Device	Decision
K231675	OneRF Ablation SystemGXD · Traditional	12/06/2023SE
K222404	Evo® sEEG SystemGZL · Traditional	10/20/2022SE
K211367	Evo sEEG SystemGZL · Traditional	09/01/2021SE

Questions and answers

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

OneRF Trigeminal Nerve Radiofrequency Probes (K251243) received a 510(k) decision of Substantially Equivalent on August 15, 2025, 115 days after the submission was received.

What is the product code of K251243?

The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.