Cleared Traditional

K062946 - TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL

K062946 is an FDA 510(k) clearance for TOP NEUROPOLE NEEDLES, manufactured by Top Corp.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K062946

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
Combination Product No
PCCP Authorized No
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.

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 57
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K062946.
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K080771 · Top Corp. · Nov 2008
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
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