FDA 510(k)

OneRF 三叉神经射频探针

K号: K251243 · 2025-08-15

决定日期2025-08-15

产品代码GXI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Neuroone Medical Technologies Corp.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K231675OneRF Ablation System K222404Evo® sEEG 系统 K211367Evo sEEG 系统

相关器械（代码：GXI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253907一次性射频消融电极ABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K242841一次性射频电极（RFDE-5/RFDE-10/RFDE-15/RFDE-20）ABBOTT MEDICAL K250213OptaBlate BVN 骨内神经消融系统（10mm探头单套件）；OptaBlate BVN 骨内神经消融系统（10mm探头双套件）Stryker Instruments K241367使用多叉电极与传统电极进行腰椎椎间盘突出症射频消融的比较Shanghai Samedical & Plastic Instruments Co., Ltd.K222281Intracept 骨内神经消融系统Relievant Medsystems, Inc.

官方来源

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