Cleared Special

CereLink ICP Monitor, CereLink ICP Extension Cable

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

About This 510(k) Submission

K183406 is an FDA 510(k) clearance for the CereLink ICP Monitor, CereLink ICP Extension Cable, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on January 11, 2019, 32 days after receiving the submission on December 10, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K183406 FDA.gov
FDA Decision Cleared 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

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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