Acutek
Country not established
- Devices
- 1
What Acutek makes
Acutek manufactures the ACU-PATCH, a Class I medical device designed for acute wound care or minor skin procedures.
The ACU-PATCH is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Acu-Patch Ref K842946
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Acutek have in the registry?
The registry currently lists 1 device for Acutek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acutek's devices?
Among its 1 most recently registered device, Acutek has devices listed in FDA 510(k) (1 device).
What risk classes do Acutek's devices fall under?
Among its 1 most recently registered device, the classes recorded for Acutek's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Acutek in the registry?
The most recently registered devices listed for Acutek include ACU-PATCH.