Cleared Traditional

Modus Nav

K183325 · Synaptive Medical, Inc. · Neurology
Jul 2019
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K183325 is an FDA 510(k) clearance for the Modus Nav, 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 July 14, 2019, 226 days after receiving the submission on November 30, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K183325 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2018
Decision Date July 14, 2019
Days to Decision 226 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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