Gc Medtech, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Gc Medtech, LLC makes
Gc Medtech, LLC manufactures applicators for medical procedures, including the GENTLECARE AR APPLICATOR and the E-App, which are designed for specific clinical applications requiring precise device placement or delivery systems.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Gentlecare Ar Applicator Ref K133922
Regimes: 510(k) Registry: 510(k)E-App Ref K142719
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gc Medtech, LLC have in the registry?
The registry currently lists 2 devices for Gc Medtech, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gc Medtech, LLC's devices?
Among its 2 most recently registered devices, Gc Medtech, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Gc Medtech, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gc Medtech, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gc Medtech, LLC in the registry?
The most recently registered devices listed for Gc Medtech, LLC include GENTLECARE AR APPLICATOR and E-App.