Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Relievant Medsystems. It received FDA 510(k) clearance on 2018-09-14 under 510(k) 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. The listed applicant is Relievant Medsystems. The 510(k) number is K180369.

When did Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) receive FDA 510(k) clearance?

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

Who is the listed applicant for Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)?

The FDA 510(k) record lists Relievant Medsystems as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06827262Intracept Minimally-invasive PROcedure for VErtebrogenic Back PainRECRUITING

Other records listing Relievant Medsystems 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.

K222281Intracept Intraosseous Nerve Ablation SystemK213836Intracept Intraosseous Nerve Ablation SystemK190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF GeneratorK171143Relievant Medsystems RF GeneratorK170827INTRACEPT Intraosseous Nerve Ablation SystemK153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

View all 7 devices →

Related Devices (Code: GXI)

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.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

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.

↑