Cleared Traditional

K130136 - DISPOSABLE AND REUSABLE CONCENTRIC NEED...

K130136 is the FDA 510(k) clearance for DISPOSABLE AND REUSABLE CONCENTRIC NEED... by Technomed Europe. It is a Class 2 Neurology device (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

Submission Details

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
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.

Device Classification

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 15
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K130136.
Guardian Needle Electrode
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AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · Stryker Spine · Jul 2011
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007