Cleared Traditional

K890061 - MODEL 3586 RESUME LEAD

K890061 is the FDA 510(k) clearance for 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 476-day FDA review.

K890061 · Medtronic Vascular · Neurology device

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Apr 1990

Decision

476d

Days

Class 2

Risk

K890061 is an FDA 510(k) clearance for the 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 April 30, 1990 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number	K890061 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 1989
Decision Date	April 30, 1990
Days to Decision	476 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

328d slower than avg

Panel avg: 148d · This submission: 476d

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 K890061.

MEDTRONIC (R) MODEL 3625 SCREENER

K903690 · Medtronic Vascular · Feb 1991

MEDTRONIC MODEL 3487A PISCES-QUAD LEAD

K910199 · Medtronic Vascular · Feb 1991

MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME

K905407 · Medtronic Vascular · Feb 1991

MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION

K892884 · Medtronic Vascular · Aug 1989

MODEL 3587A RESUME EPIDURAL LEAD

K884948 · Medtronic Vascular · Jan 1989

MODEL 3487A PISCES EPIDURAL LEAD

K885033 · Medtronic Vascular · Jan 1989

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 K890061

Medtronic Vascular

Minneapolis, MN · US

H MUELLER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

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

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