Cleared Traditional

BRIGHTMATTER NAVIGATION SYSTEM

K142024 · Synaptive Medical, Inc. · Neurology
Apr 2015
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K142024 is an FDA 510(k) clearance for the BRIGHTMATTER NAVIGATION SYSTEM, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on April 2, 2015, 251 days after receiving the submission on July 25, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K142024 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2014
Decision Date April 02, 2015
Days to Decision 251 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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