Cleared Traditional

K180369 - Intracept Intraosseous Nerve Ablation S...

K180369 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 214-day FDA review.

K180369 · Relievant Medsystems · Neurology device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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
SMITH & NEPHEW RF CANNULATE
K090955 · Smith & Nephew, Inc. · Jul 2009
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · Smith & Nephew, Inc. · Jul 2007
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc. · Nov 2006