Cleared Special

NICO BrainPath

K172433 · Nico Corporation · Neurology
Sep 2017
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K172433 is an FDA 510(k) clearance for the NICO BrainPath, a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Nico Corporation (Indianapolis, US). The FDA issued a Cleared decision on September 7, 2017, 27 days after receiving the submission on August 11, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number K172433 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2017
Decision Date September 07, 2017
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZT — Retractor, Self-retaining, For Neurosurgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4800

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