Cleared Special

K081942 - NEUROCATH AG

K081942 is an FDA 510(k) clearance for NEUROCATH AG, manufactured by Vygon Neuro. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 35-day FDA review.

K081942 · Vygon Neuro · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
35d
Days
Class 2
Risk

K081942 is an FDA 510(k) clearance for the NEUROCATH AG. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Vygon Neuro (Norristown, US). The FDA issued a Cleared decision on August 12, 2008 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Vygon Neuro devices

FDA 510(k) Submission Details - K081942

510(k) Number K081942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2008
Decision Date August 12, 2008
Days to Decision 35 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 148d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

JXG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 204
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