Cleared Traditional

K885033 - MODEL 3487A PISCES EPIDURAL LEAD

K885033 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 43-day FDA review.

K885033 · Medtronic Vascular · Neurology device
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Jan 1989
Decision
43d
Days
Class 2
Risk

K885033 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 January 17, 1989 after a review of 43 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 K885033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date January 17, 1989
Days to Decision 43 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
105d faster than avg
Panel avg: 148d · This submission: 43d
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 K885033.
MODEL 3586 RESUME LEAD
K890061 · Medtronic Vascular · Apr 1990
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
K892884 · Medtronic Vascular · Aug 1989
MODEL 3587A RESUME EPIDURAL LEAD
K884948 · Medtronic Vascular · Jan 1989
XTREL, MODEL NUMBER 3425
K883780 · Medtronic Vascular · Nov 1988
MODEL 3487A PISCES EPIDURAL LEAD
K881491 · Medtronic Vascular · May 1988
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K873675 · Medtronic Vascular · Oct 1987