Cleared Traditional

K881491 - MODEL 3487A PISCES EPIDURAL LEAD

K881491 is the FDA 510(k) clearance for MODEL 3487A 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 47-day FDA review.

K881491 · Medtronic Vascular · Neurology device

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May 1988

Decision

47d

Days

Class 2

Risk

K881491 is an FDA 510(k) clearance for the MODEL 3487A PISCES EPIDURAL LEAD. 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 May 25, 1988 after a review of 47 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	K881491 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 08, 1988
Decision Date	May 25, 1988
Days to Decision	47 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

101d faster than avg

Panel avg: 148d · This submission: 47d

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 K881491.

MODEL 3587A RESUME EPIDURAL LEAD

K884948 · Medtronic Vascular · Jan 1989

MODEL 3487A PISCES EPIDURAL LEAD

K885033 · Medtronic Vascular · Jan 1989

XTREL, MODEL NUMBER 3425

K883780 · Medtronic Vascular · Nov 1988

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

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 K881491

Medtronic Vascular

Minneapolis, MN · US

DAVID H MUELLER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

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Sourced from FDA 510(k) public files . Updated monthly.

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