Cleared Special

K183406 - CereLink ICP Monitor, CereLink ICP Extension Cable (FDA 510(k) Clearance)

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

K183406 · Integra Lifesciences Corp. · Neurology device
Jan 2019
Decision
32d
Days
Class 2
Risk

K183406 is an FDA 510(k) clearance for the CereLink ICP Monitor, CereLink ICP Extension Cable. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 32 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.

Submission Details

510(k) Number K183406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2018
Decision Date January 11, 2019
Days to Decision 32 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 162d · This submission: 32d
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.