Cleared Special

K052418 - AXXESS BUTTERFLY ANCHOR

K052418 is an FDA 510(k) clearance for AXXESS BUTTERFLY ANCHOR, 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 24-day FDA review.

K052418 · Advanced Neuromodulation Systems · Neurology device
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Sep 2005
Decision
24d
Days
Class 2
Risk

K052418 is an FDA 510(k) clearance for the AXXESS BUTTERFLY ANCHOR. 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 September 26, 2005 after a review of 24 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 - K052418

510(k) Number K052418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date September 26, 2005
Days to Decision 24 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
124d faster than avg
Panel avg: 148d · This submission: 24d
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
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