Cleared Traditional

K190504 - Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

K190504 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 63-day FDA review.

K190504 · Relievant Medsystems · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K190504

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.

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 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