Lewtek
Country not established
- Devices
- 1
What Lewtek makes
Lewtek manufactures the ENDCUP, a medical device designed for endoscopic procedures to secure and stabilize tissue during surgery, reducing the risk of complications.
The ENDCUP is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Endcup Ref K945862
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lewtek have in the registry?
The registry currently lists 1 device for Lewtek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lewtek's devices?
Among its 1 most recently registered device, Lewtek has devices listed in FDA 510(k) (1 device).
What risk classes do Lewtek's devices fall under?
Among its 1 most recently registered device, the classes recorded for Lewtek's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lewtek in the registry?
The most recently registered devices listed for Lewtek include ENDCUP.