Cleared Special

K160223 - VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (FDA 510(k) Clearance)

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

K160223 · Cook Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
70d
Days
Class 2
Risk

K160223 is an FDA 510(k) clearance for the VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic I.... Classified as Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) (product code NHC), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 8, 2016 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4100 - 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.

View all Cook Incorporated devices

Submission Details

510(k) Number K160223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2016
Decision Date April 08, 2016
Days to Decision 70 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 148d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHC Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4100
Definition Used To Gain Access To The Cavities Of The Brain For Injection Of Material Into Or Removal Of Material From The Brain.
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.