Cleared Traditional

K030461 - A127 LEAD EXTENSION

K030461 is an FDA 510(k) clearance for A127 LEAD EXTENSION, 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 71-day FDA review.

K030461 · Advanced Neuromodulation Systems · Neurology device
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Apr 2003
Decision
71d
Days
Class 2
Risk

K030461 is an FDA 510(k) clearance for the A127 LEAD EXTENSION. 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 April 24, 2003 after a review of 71 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 - K030461

510(k) Number K030461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2003
Decision Date April 24, 2003
Days to Decision 71 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
77d faster than avg
Panel avg: 148d · This submission: 71d
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 K030461.
ANS AXXESS PERCUTANEOUS LEAD
K032034 · 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
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
K030674 · Advanced Neuromodulation Systems · Mar 2003
RAPID PROGRAMMAR
K030118 · Advanced Neuromodulation Systems · Mar 2003
PAINDOC
K021518 · Advanced Neuromodulation Systems · Jun 2002