Cleared Special

K022553 - CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L

K022553 is an FDA 510(k) clearance for CAMINO INTRACRANIAL PRESSURE MONITORING..., 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 18-day FDA review.

K022553 · Integra Neurosciences · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
18d
Days
Class 2
Risk

K022553 is an FDA 510(k) clearance for the CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING,.... 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 August 20, 2002 after a review of 18 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 - K022553

510(k) Number K022553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2002
Decision Date August 20, 2002
Days to Decision 18 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
131d faster than avg
Panel avg: 149d · This submission: 18d
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 K022553.
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K022638 · Neurorecovery, Inc. · Oct 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285 · Cma Microdialysis AB · Oct 2002
ACT III VENTRICULAR CATHETER
K013705 · Innerspace, Inc. · Sep 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K020558 · Integra Neurosciences · Mar 2002
NEUROSENSOR
K013930 · Novus Monitoring, Ltd. · Feb 2002
K022553 · CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
Download PDF FDA Summary Integra Neurosciences