Cleared Special

StealthStation Cranial Software v1.3.2

K203639 · Medtronic Navigation, Inc. · Neurology
Jan 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K203639 is an FDA 510(k) clearance for the StealthStation Cranial Software v1.3.2, 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 January 13, 2021, 30 days after receiving the submission on December 14, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K203639 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2020
Decision Date January 13, 2021
Days to Decision 30 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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