Cleared Special

StealthStation Cranial Software v1.3.0

K201175 · Medtronic Navigation, Inc. · Neurology
Jun 2020
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K201175 is an FDA 510(k) clearance for the StealthStation Cranial Software v1.3.0, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on June 3, 2020, 33 days after receiving the submission on May 1, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K201175 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2020
Decision Date June 03, 2020
Days to Decision 33 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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