Cleared Traditional

K964172 - MEDTRONIC MODEL 3991A

K964172 is the FDA 510(k) clearance for MEDTRONIC MODEL 3991A by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K964172 · Medtronic Vascular · Neurology device

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Optimized for regulatory review, auditing and printing

Jul 1997

Decision

258d

Days

Class 2

Risk

K964172 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS.... 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 July 3, 1997 after a review of 258 days - an extended review cycle.

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	K964172 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 18, 1996
Decision Date	July 03, 1997
Days to Decision	258 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

110d slower than avg

Panel avg: 148d · This submission: 258d

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 K964172.

MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)

K972906 · Medtronic Vascular · Feb 1998

MEDTRONIC MODEL 3998 LEAD

K971756 · Medtronic Vascular · Feb 1998

MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER

K972043 · Medtronic Vascular · Aug 1997

BIFURCATED Y-EXTENSION

K953742 · Medtronic Vascular · Nov 1996

DUALSCREEN

K955291 · Medtronic Vascular · May 1996

MODEL NOS. 7495 AND 501826 EXTENSIONS

K954886 · Medtronic Vascular · Nov 1995

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K964172

Medtronic Vascular

Minneapolis, MN · US

DAVID H MUELLER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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