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G.tec Medical Engineering GMBH: FDA-registered device maker in Graz Steiermark, Austria, 5 510(k) clearances

Name: G.tec Medical Engineering GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

G.tec Medical Engineering GMBH is registered with the FDA (registration 3008008477) in Graz Steiermark, Austria. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 29, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008008477
Address: Herbersteinstrasse 60, Graz Steiermark, Austria, 8020
Owner or operator: G.TEC MEDICAL ENGINEERING GMBH (9084852)
Roles: Manufacturer
First device listed: December 27, 2013
Registered through: 2026
Brand names listed: cortiQ PRO, g.ESTIM FES, g.Estim PRO, g.HIamp, g.Nautilus PRO

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Manufacturer	accessdata.fda.gov
Electrode, Cortical	GYC	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Normalizing Quantitative Electroencephalograph Software	OLU	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 29, 2020	K200088	g.Estim FES	IPF	Substantially Equivalent	G.Tec Medical Engineering GmbH	accessdata.fda.gov
January 24, 2020	K191432	cortiQ PRO	OLU	Substantially Equivalent	G.Tec Medical Engineering GmbH	accessdata.fda.gov
May 4, 2018	K173684	g.Estim PRO	GYC	Substantially Equivalent	G.Tec Medical Engineering GmbH	accessdata.fda.gov
July 5, 2017	K171669	g.Nautilus PRO	GWL	Substantially Equivalent	G.Tec Medical Engineering GmbH	accessdata.fda.gov
December 20, 2012	K123255	g.HIamp	GWL	Substantially Equivalent	G.Tec Medical Engineering GmbH	accessdata.fda.gov

Compare with other makers

Updated October 29, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.