Cleared Traditional

Neural Navigator

K191422 · Soterix Medical, Inc. · Neurology
Apr 2020
Decision
313d
Days
Class 2
Risk

About This 510(k) Submission

K191422 is an FDA 510(k) clearance for the Neural Navigator, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Soterix Medical, Inc. (New York, US). The FDA issued a Cleared decision on April 6, 2020, 313 days after receiving the submission on May 29, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K191422 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2019
Decision Date April 06, 2020
Days to Decision 313 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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