Edge Medical, LLC
Country not established
- Devices
- 1
What Edge Medical, LLC makes
Edge Medical, LLC manufactures the ERBE Endorectal Balloon, a device designed for precise endorectal brachytherapy applications, delivering targeted radiation therapy to treat localized prostate cancer.
The ERBE Endorectal Balloon is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) clearance pathway. The company is based in the United States.
Catalogue
Erb Endorectal Balloon Ref K141958
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Edge Medical, LLC have in the registry?
The registry currently lists 1 device for Edge Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edge Medical, LLC's devices?
Among its 1 most recently registered device, Edge Medical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Edge Medical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Edge Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Edge Medical, LLC in the registry?
The most recently registered devices listed for Edge Medical, LLC include ERB ENDORECTAL BALLOON.