Cleared Traditional

MULTI LEAD TRIAL CABLE (K130545) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130545 · St Jude Medical · Neurology device
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Jun 2013
Decision
109d
Days
Class 2
Risk

K130545 is an FDA 510(k) clearance for the MULTI LEAD TRIAL CABLE. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by St Jude Medical (Plano, US). The FDA issued a Cleared decision on June 18, 2013 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 St Jude Medical devices

Submission Details

510(k) Number K130545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date June 18, 2013
Days to Decision 109 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
39d faster than avg
Panel avg: 148d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 71
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K130545.
Freedom Spinal Cord Stimulator (SCS) System
K182720 · Stimwave Technologies Incorporated · Mar 2019
Nalu Neurostimulation System
K183047 · Boston Scientific Neuromodulation · Mar 2019
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · Stimwave Technologies Incorporated · Sep 2018
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · Medtronic, Inc. · Oct 2010
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
K062041 · Medtronic, Inc. · Aug 2006
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
K040568 · Medtronic Vascular · Mar 2004