Cleared Special

K022222 - LAMITRODE S-SERIES (S4 AND S8) LEADS

K022222 is an FDA 510(k) clearance for LAMITRODE S-SERIES (S4 AND S8) LEADS, manufactured by Advanced Neuromodulation System,Inc. The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 30-day FDA review.

K022222 · Advanced Neuromodulation System,Inc · Neurology device
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Aug 2002
Decision
30d
Days
Class 2
Risk

K022222 is an FDA 510(k) clearance for the LAMITRODE S-SERIES (S4 AND S8) LEADS. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Advanced Neuromodulation System,Inc (Plano, US). The FDA issued a Cleared decision on August 8, 2002 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Neuromodulation System,Inc devices

FDA 510(k) Submission Details - K022222

510(k) Number K022222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2002
Decision Date August 08, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 115
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K022222.
A127 LEAD EXTENSION
K030461 · Advanced Neuromodulation Systems · Apr 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
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
K013120 · Medamicus, Inc. · Jan 2002
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · Medtronic Vascular · Aug 2001