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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 a medical device manufactured by Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2023-12-06 under approval 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. It is manufactured by Neuroone Medical Technologies Corp.. The 510(k) number is K231675.

When was OneRF Ablation System approved by the FDA?

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

What company makes OneRF Ablation System?

OneRF Ablation System is manufactured by Neuroone Medical Technologies Corp..

What is the FDA product code for OneRF Ablation System?

The FDA product code for OneRF Ablation System is GXD.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING

Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

Other Devices by Neuroone Medical Technologies Corp.

K211367Evo sEEG System K222404Evo® sEEG System K251243OneRF Trigeminal Nerve Radiofrequency Probes

Related Devices (Code: GXD)

K171143Relievant Medsystems RF GeneratorRelievant Medsystems K170242MultiGen™ 2 RF Generator SystemStryker Corporation K181864Polaris RF Ablation SystemBaylis Medical Company, Inc. K201610IonicRF GeneratorABBOTT MEDICAL K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICAL

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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