Cleared Traditional

K130136 - DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,

K130136 is an FDA 510(k) clearance for DISPOSABLE AND REUSABLE CONCENTRIC NEED..., manufactured by Technomed Europe. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K130136 · Technomed Europe · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
182d
Days
Class 2
Risk

K130136 is an FDA 510(k) clearance for the DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE .... Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on July 19, 2013 after a review of 182 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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 Technomed Europe devices

FDA 510(k) Submission Details - K130136

510(k) Number K130136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2013
Decision Date July 19, 2013
Days to Decision 182 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
34d slower than avg
Panel avg: 148d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 36
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K130136.
E-Shield Multi-paried Subdermal Needle Electrodes
K142470 · Neuroinvent, Inc. · Nov 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · Neuroinvent, Inc. · Jul 2014
MR CONDITIONAL PRESSON ELECTRODE
K130220 · Rhythmlink International, LLC · Jul 2013
PRESSON ELECTRODE
K121347 · Rhythmlink International, LLC · Jul 2012
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · Stryker Spine · Jul 2011
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
K100912 · Kirwan Surgical Products, Inc. · Aug 2010