Cleared Traditional

K062946 - TOP NEUROPOLE NEEDLES

K062946 is the FDA 510(k) clearance for TOP NEUROPOLE NEEDLES by Top Corp.. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K062946 · Top Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
140d
Days
Class 2
Risk

K062946 is an FDA 510(k) clearance for the TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Top Corp. (Dunwoody, US). The FDA issued a Cleared decision on February 15, 2007 after a review of 140 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 Top Corp. devices

Submission Details

510(k) Number K062946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date February 15, 2007
Days to Decision 140 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
8d faster than avg
Panel avg: 148d · This submission: 140d
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 K062946.
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
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K071300 · Smith & Nephew, Inc. · Jul 2007
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc. · Nov 2006
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