Cleared Traditional

K812154 - MEDTRONIC #3484 PISCES EPIDURAL LEAD

K812154 is the FDA 510(k) clearance for MEDTRONIC #3484 PISCES EPIDURAL LEAD by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K812154 · Medtronic Vascular · Neurology device
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Aug 1981
Decision
22d
Days
Class 2
Risk

K812154 is an FDA 510(k) clearance for the MEDTRONIC #3484 PISCES EPIDURAL LEAD. 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 August 20, 1981 after a review of 22 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 K812154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1981
Decision Date August 20, 1981
Days to Decision 22 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
126d faster than avg
Panel avg: 148d · This submission: 22d
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 K812154.
STIMUCORD EXTERNAL NEURAL STIM. 911A
K823530 · Cordis Corp. · Dec 1982
MEDTRONIC #1992-2 DUAL RATE TRANSMITTER
K820988 · Medtronic Vascular · Jun 1982
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
K812155 · Medtronic Vascular · Oct 1981
MYELOSTAT DORSAL CORD STIMULATOR
K811655 · Medtronic Vascular · Jul 1981
CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
K810319 · Cordis Corp. · Feb 1981
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K801384 · Medtronic Vascular · Jul 1980