Cleared Traditional

K033757 - MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM

K033757 is an FDA 510(k) clearance for MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM, manufactured by Advanced Neuromodulation Systems. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K033757 · Advanced Neuromodulation Systems · Neurology device
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Jan 2004
Decision
60d
Days
Class 2
Risk

K033757 is an FDA 510(k) clearance for the MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Advanced Neuromodulation Systems (Plano, US). The FDA issued a Cleared decision on January 30, 2004 after a review of 60 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 Advanced Neuromodulation Systems devices

FDA 510(k) Submission Details - K033757

510(k) Number K033757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2003
Decision Date January 30, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
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 99
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K033757.
TRIAL CABLE RETENTION CLIP
K050633 · Advanced Neuromodulation Systems · Apr 2005
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
K040568 · Medtronic Vascular · Mar 2004
RAPID PROGRAMMER
K040609 · Advanced Neuromodulation Systems · Mar 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