Cleared Traditional

K844115 - MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION...

K844115 is the FDA 510(k) clearance for MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION... by Medtronic Vascular. It is a Class 2 Neurology device (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

Submission Details

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.

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 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
PISCES #3487 EPIDURAL LEAD FOR SPINAL
K831746 · Medtronic Vascular · Aug 1983