Cleared Traditional

K033016 - PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892

K033016 is an FDA 510(k) clearance for PISCES Z QUAD LEAD MODEL, manufactured by Medtronic Neurological. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K033016 · Medtronic Neurological · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
34d
Days
Class 2
Risk

K033016 is an FDA 510(k) clearance for the PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCE.... Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Neurological (Minneapolis, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 34 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 Neurological devices

FDA 510(k) Submission Details - K033016

510(k) Number K033016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date October 30, 2003
Days to Decision 34 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 148d · This submission: 34d
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 113
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K033016.
RAPID PROGRAMMER
K040609 · Advanced Neuromodulation Systems · Mar 2004
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K033757 · Advanced Neuromodulation Systems · Jan 2004
LAMITRODE SPINAL CORD STIMULATION LEADS
K033429 · Advanced Neuromodulation Systems · Dec 2003
MODIFICATION TO RENEW LEAD EXTENSION
K032751 · Advanced Neuromodulation Systems · Oct 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · Advanced Neuromodulation Systems · Oct 2003
PLACER
K032349 · Advanced Neuromodulation Systems · Oct 2003