Safewire, LLC
Country not established
- Devices
- 1
What Safewire, LLC makes
Safewire, LLC manufactures the Y WIRE 2, a Class I medical device designed for specific surgical applications requiring precise wire-based constructs.
The Y WIRE 2 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
Y Wire 2 Ref K140576
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Safewire, LLC have in the registry?
The registry currently lists 1 device for Safewire, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safewire, LLC's devices?
Among its 1 most recently registered device, Safewire, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Safewire, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Safewire, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Safewire, LLC in the registry?
The most recently registered devices listed for Safewire, LLC include Y WIRE 2.