Cleared Traditional

MindsEye Expandable Port

K202072 · Minnetronix Neuro, Inc. · Neurology
Aug 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K202072 is an FDA 510(k) clearance for the MindsEye Expandable Port, a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Minnetronix Neuro, Inc. (St Paul, US). The FDA issued a Cleared decision on August 26, 2020, 30 days after receiving the submission on July 27, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number K202072 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2020
Decision Date August 26, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZT — Retractor, Self-retaining, For Neurosurgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4800

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