University of Wisconsin
Country not established
- Devices
- 1
What University of Wisconsin makes
The University of Wisconsin develops and manufactures medical devices under direct regulatory oversight, including Class II devices that require premarket notification (510(k)) clearance. These devices are designed for specific clinical applications requiring moderate risk mitigation, such as diagnostic or therapeutic tools requiring performance standards or special controls.
The portfolio is regulated under the US Food and Drug Administration’s 510(k) pathway for Class II devices, ensuring compliance with FDA requirements for safety and effectiveness. The devices are listed in the FDA’s 510(k) database, and the institution operates under US jurisdiction as a domestic manufacturer.
Catalogue
Direct Ref K852960
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does University of Wisconsin have in the registry?
The registry currently lists 1 device for University of Wisconsin. Devices recorded under merged duplicate company entries are counted once.
Which registries list University of Wisconsin's devices?
Among its 1 most recently registered device, University of Wisconsin has devices listed in FDA 510(k) (1 device).
What risk classes do University of Wisconsin's devices fall under?
Among its 1 most recently registered device, the classes recorded for University of Wisconsin's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from University of Wisconsin in the registry?
The most recently registered devices listed for University of Wisconsin include DIRECT.