Cleared Special

K020558 - LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE

K020558 is an FDA 510(k) clearance for LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICR..., manufactured by Integra Neurosciences. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 29-day FDA review.

K020558 · Integra Neurosciences · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
29d
Days
Class 2
Risk

K020558 is an FDA 510(k) clearance for the LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Neurosciences (San Diego, US). The FDA issued a Cleared decision on March 21, 2002 after a review of 29 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. 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 - K020558

510(k) Number K020558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2002
Decision Date March 21, 2002
Days to Decision 29 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
120d faster than avg
Panel avg: 149d · This submission: 29d
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 94
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K020558.
ACT III VENTRICULAR CATHETER
K013705 · Innerspace, Inc. · Sep 2002
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
K022553 · Integra Neurosciences · Aug 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
NEUROSENSOR
K013930 · Novus Monitoring, Ltd. · Feb 2002
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc. · Jun 2001
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
K010422 · Innerspace, Inc. · Jun 2001
K020558 · LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
Download PDF FDA Summary Integra Neurosciences