510(k) · Cleared
Clearedg.Estim PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.Tec Medical Engineering GmbH · GYC Electrode, Cortical
Cleared on May 4, 2018 as substantially equivalent to K082629 (Chatten Associates, Inc., 2009) after a 154-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- May 4, 2018
- Review
- 154 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944678 (1995). 6 ancestors in all, the oldest K924226 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK944678 Nihon Kohden ElectroencephalographNihon Kohden America, Inc. · 1995
- 3 generations backK992742 Neurofax, Model Eeg-1100ANihon Kohden America, Inc. · 1999
- 2 generations backK073491 Eeg-1100A Switch BoxNihon Kohden America, Inc. · 2008
- 1 generation backK082629 S12X with Esax OptionChatten Associates, Inc. · 2009
- This deviceK173684 g.Estim PROG.Tec Medical Engineering GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944678 | Nihon Kohden Electroencephalograph | Nihon Kohden America, Inc. | 1995 | — |
| −3 | K992742 | Neurofax, Model Eeg-1100A | Nihon Kohden America, Inc. | 1999 | — |
| −2 | K073491 | Eeg-1100A Switch Box | Nihon Kohden America, Inc. | 2008 | — |
| −1 | K082629 | S12X with Esax Option | Chatten Associates, Inc. | 2009 | — |
| 0 (this device) | K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GYC device
- #1 K191186 Subdural Strip/Intraoperative Split Electrode…score 11.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082629 | S12X with Esax OptionSummary page 4…Predicate Device(s) Chatten Associates S12X K082629 g.tec medical engineering GmbH, Siemingstrasse 14, 4521 Schiedlberg, Austria, Europe,… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K082629.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYC
Too few GYC 510(k)s in any year since 2007 to give a median.
Recalls per year · GYC
1in 2013
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYC
2in 2025
MAUDE reports naming product code GYC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 3 | 6 |
| 2012 | 0 | — | 1 (1) | 17 |
| 2013 | 0 | — | 1 | 5 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173684: g.Estim PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173684
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026