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FDA 510(k)

Intracept Intraosseous Nerve Ablation System

K-Number: K222281 · 2022-10-26

ApplicantRelievant Medsystems, Inc.
Decision Date2022-10-26
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Intracept Intraosseous Nerve Ablation System is a medical device manufactured by Relievant Medsystems, Inc.. It received FDA 510(k) clearance on 2022-10-26 under approval number K222281. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intracept Intraosseous Nerve Ablation System?

Intracept Intraosseous Nerve Ablation System is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Relievant Medsystems, Inc.. The 510(k) number is K222281.

When was Intracept Intraosseous Nerve Ablation System approved by the FDA?

Intracept Intraosseous Nerve Ablation System received FDA 510(k) clearance on 2022-10-26, under approval number K222281.

What company makes Intracept Intraosseous Nerve Ablation System?

Intracept Intraosseous Nerve Ablation System is manufactured by Relievant Medsystems, Inc..

What is the FDA product code for Intracept Intraosseous Nerve Ablation System?

The FDA product code for Intracept Intraosseous Nerve Ablation System is GXI.

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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) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

Other Devices by Relievant Medsystems, Inc.

K213836Intracept Intraosseous Nerve Ablation System

Related Devices (Code: GXI)

K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. K152642LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeLccs Products Limited K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems K170708OWL RF INSULATED CANNULAEDiros Technology, Inc. K163461Coolief* Cooled RF ProbeHalyard Health, Inc.

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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