Cleared Traditional

K213836 - Intracept Intraosseous Nerve Ablation S...

K213836 is an FDA 510(k) clearance for Intracept Intraosseous Nerve Ablation S..., manufactured by Relievant Medsystems, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K213836 · Relievant Medsystems, Inc. · Neurology device
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Mar 2022
Decision
92d
Days
Class 2
Risk

K213836 is an FDA 510(k) clearance for the Intracept Intraosseous Nerve Ablation System. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Relievant Medsystems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 11, 2022 after a review of 92 days - within the typical 510(k) review window.

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, Inc. devices

FDA 510(k) Submission Details - K213836

510(k) Number K213836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2021
Decision Date March 11, 2022
Days to Decision 92 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
56d faster than avg
Panel avg: 148d · This submission: 92d
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 37
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K213836.
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · Stryker Instruments · May 2025
RF Cannula
K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Jan 2025
Intracept Intraosseous Nerve Ablation System
K222281 · Relievant Medsystems, Inc. · Oct 2022
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