Cleared Special

CRX WORLD SHUNT (K990256) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K990256 · Phoenix Biomedical Corp. · Neurology device
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Apr 1999
Decision
64d
Days
Class 2
Risk

K990256 is an FDA 510(k) clearance for the CRX WORLD SHUNT. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Norristown, US). The FDA issued a Cleared decision on April 1, 1999 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Phoenix Biomedical Corp. devices

Submission Details

510(k) Number K990256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1999
Decision Date April 01, 1999
Days to Decision 64 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
84d faster than avg
Panel avg: 148d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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.

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All 257
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