Cleared Traditional

K890061 - MODEL 3586 RESUME LEAD

K890061 is an FDA 510(k) clearance for MODEL 3586 RESUME LEAD, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with 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.

FDA 510(k) Submission Details - K890061

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
327d slower than avg
Panel avg: 149d · This submission: 476d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

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 138
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K890061.
NEUROMED MODEL 1992 LS LAMITRODE LEAD
K905255 · Neuromed, Inc. · Jan 1991
NEUROMED TS8 TEST STIMULATOR
K903814 · Neuromed, Inc. · Jan 1991
NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
K901499 · Neuromed, Inc. · Jun 1990
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
K890061 · MODEL 3586 RESUME LEAD
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