Cleared Traditional

StealthStation Cranial Software, v3.1.5 (9735585)

K231976 · Medtronic Navigation, Inc. · Neurology
Oct 2023
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K231976 is an FDA 510(k) clearance for the StealthStation Cranial Software, v3.1.5 (9735585), a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on October 19, 2023, 108 days after receiving the submission on July 3, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K231976 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2023
Decision Date October 19, 2023
Days to Decision 108 days
Submission Type Traditional
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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