Cleared Traditional

K844115 - MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL

K844115 is an FDA 510(k) clearance for MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION..., 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 106-day FDA review.

K844115 · Medtronic Vascular · Neurology device
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Feb 1985
Decision
106d
Days
Class 2
Risk

K844115 is an FDA 510(k) clearance for the MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL. 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 February 6, 1985 after a review of 106 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

FDA 510(k) Submission Details - K844115

510(k) Number K844115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date February 06, 1985
Days to Decision 106 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
42d faster than avg
Panel avg: 148d · This submission: 106d
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 117
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K844115.
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K873675 · Medtronic Vascular · Oct 1987
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · Medtronic Vascular · May 1986
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K852827 · Cordis Corp. · Aug 1985
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
K841584 · Medtronic Vascular · May 1984
SPINAL CORD STIMULATION SYS SE-4
K833990 · Medtronic Vascular · Mar 1984
NEURAL STIMULATOR MONITOR
K833809 · Instromedix, Inc. · Dec 1983