Cleared Traditional

K833990 - SPINAL CORD STIMULATION SYS SE-4

K833990 is the FDA 510(k) clearance for SPINAL CORD STIMULATION SYS SE-4 by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K833990 · Medtronic Vascular · Neurology device

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Mar 1984

Decision

119d

Days

Class 2

Risk

K833990 is an FDA 510(k) clearance for the SPINAL CORD STIMULATION SYS SE-4. 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 March 19, 1984 after a review of 119 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	K833990 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 21, 1983
Decision Date	March 19, 1984
Days to Decision	119 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

29d faster than avg

Panel avg: 148d · This submission: 119d

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 K833990.

CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A

K852827 · Cordis Corp. · Aug 1985

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL

K844115 · Medtronic Vascular · Feb 1985

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL

K841584 · Medtronic Vascular · May 1984

PISCES #3487 EPIDURAL LEAD FOR SPINAL

K831746 · Medtronic Vascular · Aug 1983

STIMUCORD EXTERNAL NEURAL STIM. 911A

K823530 · Cordis Corp. · Dec 1982

MEDTRONIC #1992-2 DUAL RATE TRANSMITTER

K820988 · Medtronic Vascular · Jun 1982

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 K833990

Medtronic Vascular

Walker, MI · US

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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