Cleared Traditional

K913934 - MEDTRONIC MODEL 3586 RESUME LEAD

K913934 is the FDA 510(k) clearance for MEDTRONIC MODEL 3586 RESUME LEAD by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K913934 · Medtronic Vascular · Neurology device
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Jan 1992
Decision
141d
Days
Class 2
Risk

K913934 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3586 RESUME LEAD. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 22, 1992 after a review of 141 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 Medtronic Vascular devices

Submission Details

510(k) Number K913934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date January 22, 1992
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 148d · This submission: 141d
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 74
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K913934.
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K921558 · Medtronic Vascular · Jul 1992
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MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433 · Medtronic Vascular · Dec 1991
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
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MEDTRONIC 3625 SCREENER SYSTEM
K913442 · Medtronic Vascular · Nov 1991