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FDA 510(k)

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

K-Number: K190504 · 2019-05-03

ApplicantRelievant Medsystems
Decision Date2019-05-03
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is a medical device manufactured by Relievant Medsystems. It received FDA 510(k) clearance on 2019-05-03 under approval number K190504. 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 (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Relievant Medsystems. The 510(k) number is K190504.

When was Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator approved by the FDA?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator received FDA 510(k) clearance on 2019-05-03, under approval number K190504.

What company makes Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is manufactured by Relievant Medsystems.

What is the FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

The FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is GXI.

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Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41517921 Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. Journal of cardiovascular electrophysiology (2026) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Relievant Medsystems

K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set K171143Relievant Medsystems RF Generator K170827INTRACEPT Intraosseous Nerve Ablation System K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)

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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