Cleared Traditional

K190504 - Intracept Intraosseous Nerve Ablation S...

K190504 is the FDA 510(k) clearance for Intracept Intraosseous Nerve Ablation S... by Relievant Medsystems. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K190504 · Relievant Medsystems · Neurology device
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Optimized for regulatory review, auditing and printing
May 2019
Decision
63d
Days
Class 2
Risk

K190504 is an FDA 510(k) clearance for the Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseo.... 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 May 3, 2019 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Relievant Medsystems devices

Submission Details

510(k) Number K190504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date May 03, 2019
Days to Decision 63 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
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K190504.
COOLIEF Cooled Radiofrequency Kit Advanced
K203066 · Avanos Medical, Inc. · Dec 2020
Vesta RF Cannula
K190259 · Biomerics · Feb 2020
LCCS VC-S RF Cannula
K191293 · Lccs Products Limited · Jan 2020
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 (component Intracept RF Probe)
K180369 · Relievant Medsystems · Sep 2018