Data / Medical devices / Turkey / Geotek Medikal Ve Saglik Hiz. Ltd. Sti
Geotek Medikal Ve Saglik Hiz. Ltd. Sti: FDA-registered device maker in Ankara, Turkey, 2 510(k) clearances
Geotek Medikal Ve Saglik Hiz. Ltd. Sti is registered with the FDA (registration 3013727803) in Ankara, Turkey. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 21, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013727803
- Address
- Eskisehir Yolu 42. Km ASO 2 Alci OSB 2014 Cad No:11 Sincan, Ankara, Turkey, 06909
- Owner or operator
- Geotek Medikal ve Saglik HIz. Ltd. Sti (10056293)
- Roles
- Manufacturer
- First device listed
- November 26, 2017
- Registered through
- 2026
- Brand names listed
- Disposable Needle Guide, GTK01, Disposable Needle Guide, GTK02, Disposable Needle Guide, GTK03, Disposable Needle Guide, GTK04, Disposable Needle Guide, GTK05, Disposable Needle Guide, GTK06, Disposable Needle Guide, GTK07, Disposable Needle Guide, GTK08 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2023 | K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument | KNW | Substantially Equivalent | Geotek Medikal Ltd Sti | accessdata.fda.gov |
| June 1, 2017 | K170741 | GTK Disposable Needle Guides | ITX | Substantially Equivalent | Geotek Medikal Ltd Sti | accessdata.fda.gov |
Compare with other makers
Updated April 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.