Cleared Traditional

K002392 - VENTRIX TRUE TECH VENTRICULAR TUNNELING...

K002392 is an FDA 510(k) clearance for VENTRIX TRUE TECH VENTRICULAR TUNNELING..., manufactured by Integra Neurocare, LLC. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K002392 · Integra Neurocare, LLC · Neurology device
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Nov 2000
Decision
87d
Days
Class 2
Risk

K002392 is an FDA 510(k) clearance for the VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Neurocare, LLC (San Diego, US). The FDA issued a Cleared decision on November 2, 2000 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra Neurocare, LLC devices

FDA 510(k) Submission Details - K002392

510(k) Number K002392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date November 02, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 41
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K002392.
LICOX PMO BRAIN MONITORING SYSTEM
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CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc. · Oct 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · Johnson & Johnson Professionals, Inc. · Jul 1999
CODMAN INTRACRANIAL BOLT
K974088 · Johnson & Johnson Professionals, Inc. · Jan 1998