FDA 510(k)

OneRF Trigeminal Nerve Radiofrequency Probes

Número K: K251243 · 2025-08-15

RequerenteNeuroone Medical Technologies Corp.

Data da decisão2025-08-15

Código do produtoGXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Neuroone Medical Technologies Corp. como candidato(a)

K231675OneRF Ablation System K222404Evo® sEEG System K211367Evo sEEG System

Dispositivos Relacionados (Código: GXI)

K253907Disposable Radiofrequency CannulaABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.