Cleared Special

K033704 - MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS

K033704 is an FDA 510(k) clearance for MODIFICATION TO LUMBO-PERITONEAL SHUNTS..., manufactured by Vygon Us, LLC. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 184-day FDA review.

K033704 · Vygon Us, LLC · Neurology device
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May 2004
Decision
184d
Days
Class 2
Risk

K033704 is an FDA 510(k) clearance for the MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Vygon Us, LLC (Norristown, US). The FDA issued a Cleared decision on May 27, 2004 after a review of 184 days - an extended review 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. Standard predicate reliance. 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 - K033704

510(k) Number K033704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date May 27, 2004
Days to Decision 184 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
35d slower than avg
Panel avg: 149d · This submission: 184d
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 253
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K033704.
LOW FLOW OSV II HYDROCEPHALUS VALVE
K042192 · Integra Neurosciences Implants S.A. · Sep 2004
MEDTRONIC PS MEDICAL STRATA VALVE
K040943 · Medtronic Neurosurgery · Jun 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004
PHOENIX INFUSION CATHETER
K033017 · Phoenix Biomedical · Apr 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
K031097 · Sophysa SA · Feb 2004
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
K040201 · Integra Neurosciences Implants S.A. · Feb 2004
K033704 · MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
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