Cleared Traditional

K841584 - MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL

K841584 is the FDA 510(k) clearance for MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K841584 · Medtronic Vascular · Neurology device
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May 1984
Decision
27d
Days
Class 2
Risk

K841584 is an FDA 510(k) clearance for the MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 14, 1984 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K841584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date May 14, 1984
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 K841584.
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · Medtronic Vascular · May 1986
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K852827 · Cordis Corp. · Aug 1985
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
K844115 · Medtronic Vascular · Feb 1985
SPINAL CORD STIMULATION SYS SE-4
K833990 · Medtronic Vascular · Mar 1984
PISCES #3487 EPIDURAL LEAD FOR SPINAL
K831746 · Medtronic Vascular · Aug 1983
STIMUCORD EXTERNAL NEURAL STIM. 911A
K823530 · Cordis Corp. · Dec 1982