Cleared Traditional

K173684 - g.Estim PRO

K173684 is the FDA 510(k) clearance for g.Estim PRO by G.Tec Medical Engineering GmbH. It is a Class 2 Neurology device (product code GYC) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K173684 · G.Tec Medical Engineering GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
154d
Days
Class 2
Risk

K173684 is an FDA 510(k) clearance for the g.Estim PRO. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AU). The FDA issued a Cleared decision on May 4, 2018 after a review of 154 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all G.Tec Medical Engineering GmbH devices

Submission Details

510(k) Number K173684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 148d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Tuv Sud America, Inc.
Olaf Teichert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GYC Electrode, Cortical

All 14
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K173684.
NeuroOne Cortical Electrode
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AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH · Mar 2019
SD LTM STIM Cortical Stimulator
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INTEGRA ELECTRODE TUNNELING NEEDLE
K102802 · Integra LifeSciences Corporation · Nov 2010
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc. · Aug 1997
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424 · Radionics, Inc. · Nov 1993