Cleared Special

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit

K173192 · Codman & Shurtleff, Inc. · Neurology
Nov 2017
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K173192 is an FDA 510(k) clearance for the CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on November 8, 2017, 37 days after receiving the submission on October 2, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K173192 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2017
Decision Date November 08, 2017
Days to Decision 37 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

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