Cleared Special

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

K201118 · Medtronic, Inc. · Neurology
May 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K201118 is an FDA 510(k) clearance for the Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level, 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 May 26, 2020, 29 days after receiving the submission on April 27, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K201118 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2020
Decision Date May 26, 2020
Days to Decision 29 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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