# K173684: g.Estim PRO

- Pathway: 510(k) (Traditional)
- Applicant: G.Tec Medical Engineering GmbH
- Decided: May 4, 2018 after 154 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944678 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082629: S12X with Esax Option, Chatten Associates, Inc. (2009) Summary page 4.

## Indications for use
The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by medically trained and qualified personnel within a medical environment.

Source page: https://510kreport.com/device/K173684
Methodology: https://510kreport.com/methodology