g.Estim PRO
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- g.Estim PRO FDA UDI
- Generic Name
- Cortical electrode FDA UDI
- Device Name
- g.Estim PRO EUDAMEDg.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation. FDA UDI
- Model / Reference
- 1150 EUDAMED1 FDA UDI
- Description
- g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation. FDA UDI
Identifiers
- Catalog Number
- 1150 FDA UDI
- Primary DI / UDI-DI
- EBCI11500 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EBCI11500 EUDAMED
- 510(k) Number
- FDA Product Code
- GYC FDA 510(k)FDA UDI
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
- GMDN Term
- Cortical electrode FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.1310 FDA 510(k)
- Regulation Number
- 882.1310 FDA 510(k)FDA UDI
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
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.
Frequently asked questions
What clinical and research applications is the g.Estim PRO primarily used for?
The g.Estim PRO Cortical Stimulator is designed for functional brain mapping, electrical cortical stimulation, and real-time neuromodulation. It supports applications in CCEP (Cortical Control of Epileptic Patients) research and integration with ECoG (Electrocorticography) workflows, making it suitable for both clinical and research settings focused on neurology.
Is the g.Estim PRO a single-use or reusable device, and how does this affect its use in clinical settings?
The g.Estim PRO is explicitly supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients or procedures. This design allows for cost-effective deployment in clinical and research environments where multiple sessions may be required, though proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality.
What types of connectors does the g.Estim PRO use, and how does this impact electrode compatibility?
The g.Estim PRO features connectors designed for bipolar stimulation electrodes, including both anode and cathode. This setup ensures compatibility with standard cortical electrode configurations used in functional brain mapping and neuromodulation, allowing clinicians and researchers to attach electrodes tailored for their specific applications in neurology.
What regulatory pathways has the g.Estim PRO followed, and what does this mean for its use in the U.S.?
The g.Estim PRO has obtained FDA 510(k) clearance and complies with the Medical Device Directive (MDD). In the U.S., this clearance indicates that the device is considered *substantially equivalent* to a legally marketed predicate, meaning it meets FDA standards for safety and effectiveness as determined by the Neurology Advisory Committee. Clinicians can rely on this authorization for use in clinical and research settings.
How should the g.Estim PRO be stored to maintain its performance and longevity?
While specific storage instructions are not detailed in the provided data, as a reusable medical device, the g.Estim PRO should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and contamination. Proper maintenance, including regular calibration and adherence to manufacturer guidelines, is essential to ensure reliable performance over repeated use in clinical or research applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: g.Estim PRO Cortical Stimulator for Functional Brain Mapping | g.tec ..., g.tec medical engineering | Brain-Computer Interfaces & Neurotechnology, g.tec medical engineering GmbH 1150 g.Estim PRO - RevMed
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173684 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- g.tec medical engineering GmbH
Sources (3)
- FDA 510(k) K173684 24 fields · synced Sep 18, 2026
- FDA UDI 975601ec-0643-4168-8b8f-a9e1d308ba81 37 fields · synced May 30, 2026
- EUDAMED 58e99442-6017-4f5b-9cec-7031d8b31170 61 fields · synced Jul 28, 2026