Cleared Traditional

g.Estim PRO

K173684 · G.Tec Medical Engineering GmbH · Neurology
May 2018
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K173684 is an FDA 510(k) clearance for the g.Estim PRO, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AU). The FDA issued a Cleared decision on May 4, 2018, 154 days after receiving the submission on December 1, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K173684 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2017
Decision Date May 04, 2018
Days to Decision 154 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

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