Cleared Special

K091993 - RAPID PROGRAMMER, VERSION 3.3.0

K091993 is an FDA 510(k) clearance for RAPID PROGRAMMER, manufactured by Advanced Neuromodulation Systems, Inc. (Ans Inc.). The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 29-day FDA review.

K091993 · Advanced Neuromodulation Systems, Inc. (Ans Inc.) · Neurology device
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Jul 2009
Decision
29d
Days
Class 2
Risk

K091993 is an FDA 510(k) clearance for the RAPID PROGRAMMER, VERSION 3.3.0. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Advanced Neuromodulation Systems, Inc. (Ans Inc.) (Plano, US). The FDA issued a Cleared decision on July 31, 2009 after a review of 29 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.

FDA 510(k) Submission Details - K091993

510(k) Number K091993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2009
Decision Date July 31, 2009
Days to Decision 29 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
120d faster than avg
Panel avg: 149d · This submission: 29d
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 135
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K091993 · RAPID PROGRAMMER, VERSION 3.3.0
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