Cleared Traditional

K032034 - ANS AXXESS PERCUTANEOUS LEAD

K032034 is an FDA 510(k) clearance for ANS AXXESS PERCUTANEOUS LEAD, 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 94-day FDA review.

K032034 · Advanced Neuromodulation Systems · Neurology device
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Oct 2003
Decision
94d
Days
Class 2
Risk

K032034 is an FDA 510(k) clearance for the ANS AXXESS PERCUTANEOUS LEAD. 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 October 3, 2003 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Neuromodulation Systems devices

FDA 510(k) Submission Details - K032034

510(k) Number K032034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2003
Decision Date October 03, 2003
Days to Decision 94 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
54d faster than avg
Panel avg: 148d · This submission: 94d
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 K032034.
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
PLACER
K032349 · Advanced Neuromodulation Systems · Oct 2003
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
K032561 · Medtronic Vascular · Sep 2003
A127 LEAD EXTENSION
K030461 · Advanced Neuromodulation Systems · Apr 2003