Cleared Traditional

K180369 - Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)

K180369 is an FDA 510(k) clearance for Intracept Intraosseous Nerve Ablation S..., manufactured by Relievant Medsystems. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K180369 · Relievant Medsystems · Neurology device
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Sep 2018
Decision
214d
Days
Class 2
Risk

K180369 is an FDA 510(k) clearance for the Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe). Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Relievant Medsystems (Sunnyvale, US). The FDA issued a Cleared decision on September 14, 2018 after a review of 214 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Relievant Medsystems devices

FDA 510(k) Submission Details - K180369

510(k) Number K180369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date September 14, 2018
Days to Decision 214 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 148d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 53
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K180369.
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
K190504 · Relievant Medsystems · May 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · Boston Scientific Corporation · Mar 2019
Rulo Radiofrequency Lesion Probe
K190256 · Epimed International, Inc. · Mar 2019
INTRACEPT Intraosseous Nerve Ablation System
K170827 · Relievant Medsystems · Aug 2017
OWL RF INSULATED CANNULAE
K170708 · Diros Technology, Inc. · Jun 2017
Coolief* Cooled RF Probe
K163461 · Halyard Health, Inc. · Apr 2017