G.Tec Medical Engineering GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “G.Tec Medical Engineering GmbH” (first 2006, latest 2020), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 108 days. Since 2017 the median was 197 days, against 154 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 63 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 2018 | 1 | 154 |
| 2019 | 0 | — |
| 2020 | 2 | 264 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name G.Tec Medical Engineering GmbH took a median 197 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | 3 | 3 |
| GYC | Electrode, Cortical | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| OLU | Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (1)
Most recent G.Tec Medical Engineering GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200088 | g.Estim FES | IPF | 2020-10-29 | 288 |
| K191432 | cortiQ PRO | OLU | 2020-01-24 | 240 |
| K173684 | g.Estim PRO | GYC | 2018-05-04 | 154 |
| K171669 | g.Nautilus PRO | GWL | 2017-07-05 | 30 |
| K123255 | g.HIamp | GWL | 2012-12-20 | 63 |
| K060803 | G.USBAMP | GWL | 2006-05-02 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named G.Tec Medical Engineering GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named G.Tec Medical Engineering GmbH is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07537530: Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback (Completed, started 2025-06-03)
- NCT06690931: Neurofeedback Rehabilitation With FES and VR for PD (Recruiting, started 2024-12-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under G.Tec Medical Engineering GmbH?
FDA lists 6 510(k) clearances under the applicant name “G.Tec Medical Engineering GmbH” (first 2006, latest 2020), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by G.Tec Medical Engineering GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name G.Tec Medical Engineering GmbH is 108 days. Since 2017: 197 days, versus 154 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under G.Tec Medical Engineering GmbH?
The most frequent FDA product codes under this applicant name are GWL (Amplifier, Physiological Signal, 3); GYC (Electrode, Cortical, 1); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 6 G.Tec Medical Engineering GmbH clearances with predicates and recalls
- Run predicate analysis for product code GWL, G.Tec Medical Engineering GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.