# g.Estim PRO

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/g-estim-pro-gyc>
- Manufacturer: [g.tec medical engineering GmbH](https://devicerts.com/manufacturers/gtec-medical-engineering-gmbh) (Austria)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: GYC
- EMDN: Z12101106 NEUROLOGICAL STIMULATORS
- GMDN: Cortical electrode (32545)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The g.Estim PRO Cortical Stimulator is a constant-current, biphasic electrical stimulator designed for cortical stimulation. It is classified as a cortical electrode device and is used for functional brain mapping, electrical cortical stimulation, and real-time neuromodulation, including applications in CCEP research and ECoG workflows.

This device is supplied as a reusable medical instrument and is intended for use in clinical and research settings. It features connectors for bipolar stimulation electrodes (anode and cathode) and operates under regulatory authorisations including FDA 510(k) clearance and MDD compliance. The stimulator is manufactured by g.tec medical engineering GmbH, based in Schiedlberg, Austria, and is categorised under product code GYC with a device class of II.

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-EBCI11500 · UDI-DI EBCI11500 · registered 2021-11-12 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI EBCI11500 · listed 2018-05-30 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K173684 · decision 2018-05-04 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Cortical electrode [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 1150 [EUDAMED, FDA GUDID (AccessGUDID)]; 1 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: EBCI11500 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-EBCI11500 [EUDAMED]
- 510(k) Number: K173684 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: GYC [FDA 510(k), FDA GUDID (AccessGUDID)]
- EMDN code: Z12101106 [EUDAMED]
- GMDN term: Cortical electrode (32545) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 882.1310 [FDA 510(k), FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Austria [EUDAMED]
- Advisory committee: Neurology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: g.Estim PRO, g.tec medical engineering GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/g-estim-pro-gyc (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/g-estim-pro-gyc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/g-estim-pro-gyc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.