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g.Estim PRO

by g.tec medical engineering GmbH

510(k) K173684Ref 1150

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173684↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EBCI11500 Basic UDI-DI EBCI11500UDI-DIDate12 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID NumberEBCI11500 UDI-DI Date30 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173684 Date4 May 2018ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-EBCI11500 registered 12 Nov 2021 Active
  • FDA 510(k) K173684 decided 4 May 2018 Active
  • FDA GUDID UDI-DI EBCI11500 listed 30 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173684
  2. Listed FDA GUDID EBCI11500
  3. Registered EUDAMED B-EBCI11500

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Cortical electrode
Model / Ref / Catalog
1150, 1
Primary DI / UDI-DI
EBCI11500
Basic UDI-DI
B-EBCI11500
510(k) Number
FDA product code
GYC
EMDN code
Z12101106 Neurological stimulators
GMDN term
Cortical electrode
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 882.1310
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / referenceEUDAMED
1150
510(k)
—
GUDID
1
Device classEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

From the manufacturer

g.Estim PRO is a programmable cortical stimulator for functional brain mapping, electrical cortical stimulation, CCEP research, ECoG workflows and real-time neuromodulation.

Source: gtec.at

g.tec medical engineering develops advanced neurotechnology solutions, including brain-computer interfaces (BCIs) and high-precision biosignal acquisition systems, enabling researchers and clinicians to measure and interpret brain activity with exceptional accuracy.

Source: gtec.at

Devices cleared under K173684

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K173684
UDI-DISize and differences
g.Estim PRO 1
g.tec medical engineering GmbH
1150 / 1EBCI11500 —On the market

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Properties

  • Prescription use
  • Serial number
Other properties (21, all answered No)