Cleared Traditional

K153272 - INTRACEPT Flexible Bi-Polar RF Probe an...

K153272 is the FDA 510(k) clearance for INTRACEPT Flexible Bi-Polar RF Probe an... by Relievant Medsystems. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K153272 · Relievant Medsystems · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
240d
Days
Class 2
Risk

K153272 is an FDA 510(k) clearance for the INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Relievant Medsystems (Redwood City, US). The FDA issued a Cleared decision on July 9, 2016 after a review of 240 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 K153272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date July 09, 2016
Days to Decision 240 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 148d · This submission: 240d
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 31
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K153272.
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
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