Geotek Medikal Ltd Sti
TürkiyeFDA applicant, unverified
- Devices
- 2
What Geotek Medikal Ltd Sti makes
Geotek Medikal Ltd Sti manufactures disposable needle guides and automated/semiautomatic biopsy needles, including single-use and reusable instruments designed for tissue sampling procedures. Products include the Estacore-Pro, Geotek Semiautomatic Biopsy Needle, and Maxicore-M series, which integrate needle and gun systems for core biopsy applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s portfolio is authorised for commercial distribution in the United States, where the manufacturer is based.
Catalogue
GTK Disposable Needle Guides Ref K170741
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Geotek Medikal Ltd Sti have in the registry?
The registry currently lists 2 devices for Geotek Medikal Ltd Sti. Devices recorded under merged duplicate company entries are counted once.
Which registries list Geotek Medikal Ltd Sti's devices?
Among its 2 most recently registered devices, Geotek Medikal Ltd Sti has devices listed in FDA 510(k) (2 devices).
What risk classes do Geotek Medikal Ltd Sti's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Geotek Medikal Ltd Sti's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Geotek Medikal Ltd Sti in the registry?
The most recently registered devices listed for Geotek Medikal Ltd Sti include GTK Disposable Needle Guides and Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument.