Cleared Special

CereLink ICP Monitor

K210993 · Integra Lifesciences Production Corporation · Neurology
Apr 2021
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K210993 is an FDA 510(k) clearance for the CereLink ICP Monitor, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on April 30, 2021, 28 days after receiving the submission on April 2, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K210993 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2021
Decision Date April 30, 2021
Days to Decision 28 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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