Cleared Special

K063467 - SMITH & NEPHEW RF CANNULAE

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

K063467 · Smith & Nephew, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K063467

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.

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 55
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K063467.
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · Smith & Nephew, Inc. · Jul 2007
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K071745 · Baylis Medical Co., Inc. · Jul 2007
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
K062937 · Baylis Medical Co., Inc. · Jan 2007
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K060397 · PAJUNK GmbH Medizintechnologie · Aug 2006
COSMAN CSK RF CANNULA
K060799 · Cosman Medical, Inc. · May 2006
LESIONPOINT RF CANNULA
K053415 · Cosman Medical, Inc. · Apr 2006