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FDA 510(k)

OneRF Ablation System

K-Number: K231675 · 2023-12-06

ApplicantNeuroone Medical Technologies Corp.
Decision Date2023-12-06
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OneRF Ablation System 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 2023-12-06 under 510(k) number K231675. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OneRF Ablation System?

OneRF Ablation System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Neuroone Medical Technologies Corp.. The 510(k) number is K231675.

When did OneRF Ablation System receive FDA 510(k) clearance?

OneRF Ablation System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231675.

Who is the listed applicant for OneRF Ablation System?

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 Ablation System?

The FDA product code for OneRF Ablation System is GXD.

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.

K251243OneRF Trigeminal Nerve Radiofrequency ProbesK222404Evo® sEEG SystemK211367Evo sEEG System

Related Devices (Code: GXD)

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.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632Racz Neurostat RF GeneratorEpimed InternationalK220122APEX 6Rf Innovations, Inc.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICALK201610IonicRF GeneratorABBOTT MEDICAL

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.

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