Cleared Special

K040201 - MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM

K040201 is an FDA 510(k) clearance for MODIFICATION TO BURR HOLE VALVE AND SHU..., manufactured by Integra Neurosciences Implants S.A.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 28-day FDA review.

K040201 · Integra Neurosciences Implants S.A. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
28d
Days
Class 2
Risk

K040201 is an FDA 510(k) clearance for the MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Neurosciences Implants S.A. (Planisboro, US). The FDA issued a Cleared decision on February 26, 2004 after a review of 28 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.

FDA 510(k) Submission Details - K040201

510(k) Number K040201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2004
Decision Date February 26, 2004
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 149d · This submission: 28d
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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K040201.
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
K033704 · Vygon Us, LLC · May 2004
PHOENIX INFUSION CATHETER
K033017 · Phoenix Biomedical · Apr 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
K031097 · Sophysa SA · Feb 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850 · Medtronic Neurosurgery · Jan 2004
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
K033698 · Integra Neurosciences Implants S.A. · Dec 2003
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
K030468 · Phoenix Biomedical Corp. · Oct 2003
K040201 · MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
Download PDF FDA Summary Integra Neurosciences…