Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)

K-Number: K180369 · 2018-09-14

ApplicantRelievant Medsystems
Decision Date2018-09-14
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is a medical device manufactured by Relievant Medsystems. It received FDA 510(k) clearance on 2018-09-14 under approval number K180369. 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 (component Intracept RF Probe)?

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Relievant Medsystems. The 510(k) number is K180369.

When was Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) approved by the FDA?

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) received FDA 510(k) clearance on 2018-09-14, under approval number K180369.

What company makes Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)?

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is manufactured by Relievant Medsystems.

What is the FDA product code for Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)?

The FDA product code for Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) is GXI.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_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) 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

K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set K171143Relievant Medsystems RF Generator K170827INTRACEPT Intraosseous Nerve Ablation System K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

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.

↑