Cleared Special

K053244 - LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT (FDA 510(k) Clearance)

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

K053244 · Integra Lifesciences Corp. · Neurology device
May 2006
Decision
170d
Days
Class 2
Risk

K053244 is an FDA 510(k) clearance for the LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 170 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - 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.

Submission Details

510(k) Number K053244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date May 10, 2006
Days to Decision 170 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 163d · This submission: 170d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.