G.tec Medical Engineering GmbH
SCHIEDLBERG Oberosterreich, AT
G.TEC MEDICAL ENGINEERING GMBH appears in FDA device records in SCHIEDLBERG Oberosterreich, AT. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for G.tec Medical Engineering GmbH between 2006 and 2020. The busiest year on record is 2020, with 2. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200088 | g.Estim FES | IPF | Substantially Equivalent | |
| K191432 | cortiQ PRO | OLU | Substantially Equivalent | |
| K173684 | g.Estim PRO | GYC | Substantially Equivalent | |
| K171669 | g.Nautilus PRO | GWL | Substantially Equivalent | |
| K123255 | g.HIamp | GWL | Substantially Equivalent | |
| K060803 | G.USBAMP | GWL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005713796 | 3005713796 | G.TEC MEDICAL ENGINEERING GMBH | 14 SIERNINGSTRASSE, SCHIEDLBERG Oberosterreich 4521 AT | 2026 | |
| 3008008477 | 3008008477 | G.TEC MEDICAL ENGINEERING GMBH | Herbersteinstrasse 60, Graz Steiermark 8020 AT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain