Cleared Special

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags

K200630 · Medtronic, Inc. · Neurology
Apr 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200630 is an FDA 510(k) clearance for the Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Medtronic, Inc. (Irvine, US). The FDA issued a Cleared decision on April 9, 2020, 30 days after receiving the submission on March 10, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K200630 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2020
Decision Date April 09, 2020
Days to Decision 30 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

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

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