Cleared Special

K053244 - LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT

K053244 is an FDA 510(k) clearance for LICOX IT2 COMPLETE BRAIN TUNNELING PROB..., manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 170-day FDA review.

K053244 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K053244

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 149d · This submission: 170d
Pathway characteristics
Modification to existing cleared device.

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 104
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K053244.
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505 · Integra LifeSciences Corporation · Aug 2007
PRESSIO ICP MONITORING SYSTEM
K062584 · Sophysa SA · Jul 2007
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640 · Integra LifeSciences Corporation · Jul 2006
CMA CEREBRAL TISSUE MONITORING SYSTEM
K060554 · Cma Microdialysis AB · May 2006
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K051599 · Neurorecovery, Inc. · Jul 2005
NEUROSYSTEMS 1TM MONITOR
K050702 · Neurosystems, LLC · May 2005
K053244 · LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
Download PDF FDA Summary Integra Lifesciences …