Cleared Special

K063467 - SMITH & NEPHEW RF CANNULAE

K063467 is the FDA 510(k) clearance for SMITH & NEPHEW RF CANNULAE by Smith & Nephew, Inc.. It is a Class 2 Neurology device (product code GXI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K063467 · Smith & Nephew, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
28d
Days
Class 2
Risk

K063467 is an FDA 510(k) clearance for the SMITH & NEPHEW RF CANNULAE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 21, 2006 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K063467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2006
Decision Date November 21, 2006
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K063467.
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
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K060397 · PAJUNK GmbH Medizintechnologie · Aug 2006
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · Stryker Instruments · May 2005
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004