Cleared Traditional

StealthStation System with Cranial Software

K153660 · Medtronic Navigation, Inc. · Neurology
Sep 2016
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K153660 is an FDA 510(k) clearance for the StealthStation System with Cranial Software, 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 September 14, 2016, 268 days after receiving the submission on December 21, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K153660 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date September 14, 2016
Days to Decision 268 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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