Cleared Traditional

INTEGRA LICOX PTO2 MONITOR

K131184 · Integra Lifesciences Corp. · Neurology
Aug 2013
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K131184 is an FDA 510(k) clearance for the INTEGRA LICOX PTO2 MONITOR, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Integra Lifesciences Corp. (Burlington, US). The FDA issued a Cleared decision on August 30, 2013, 127 days after receiving the submission on April 25, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K131184 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2013
Decision Date August 30, 2013
Days to Decision 127 days
Submission Type Traditional
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

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

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