Cleared Special

K050922 - ANS SCS ACCESSORY KIT

K050922 is an FDA 510(k) clearance for ANS SCS ACCESSORY KIT, manufactured by Advanced Neuromodulation Systems. The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 35-day FDA review.

K050922 · Advanced Neuromodulation Systems · Neurology device
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May 2005
Decision
35d
Days
Class 2
Risk

K050922 is an FDA 510(k) clearance for the ANS SCS ACCESSORY KIT. 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 May 18, 2005 after a review of 35 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 Systems devices

FDA 510(k) Submission Details - K050922

510(k) Number K050922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2005
Decision Date May 18, 2005
Days to Decision 35 days
Submission Type Special
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
113d faster than avg
Panel avg: 148d · This submission: 35d
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 99
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K050922.
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