Cleared Traditional

K080771 - TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC

K080771 is an FDA 510(k) clearance for TOP NEUROPOLE NEEDLE, 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 236-day FDA review.

K080771 · Top Corp. · Neurology device
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Nov 2008
Decision
236d
Days
Class 2
Risk

K080771 is an FDA 510(k) clearance for the TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC. 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 November 10, 2008 after a review of 236 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 Top Corp. devices

FDA 510(k) Submission Details - K080771

510(k) Number K080771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2008
Decision Date November 10, 2008
Days to Decision 236 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
88d slower than avg
Panel avg: 148d · This submission: 236d
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 K080771.
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc. · Aug 2010
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · Baylis Medical Co., Inc. · Oct 2009
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
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K071745 · Baylis Medical Co., Inc. · Jul 2007
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
K062946 · Top Corp. · Feb 2007