Galen Robotics
Country not established
- Devices
- 1
What Galen Robotics makes
Galen Robotics manufactures the Galen ES Cooperative Surgical Assistant Platform, a robotic system designed to assist in surgical procedures by providing precise, cooperative control for minimally invasive operations.
The company’s portfolio is regulated under FDA Class II devices, with the Galen ES platform authorised via the 510(k) pathway. The platform is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Galen Robotics have in the registry?
The registry currently lists 1 device for Galen Robotics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Galen Robotics's devices?
Among its 1 most recently registered device, Galen Robotics has devices listed in FDA 510(k) (1 device).
What risk classes do Galen Robotics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Galen Robotics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Galen Robotics in the registry?
The most recently registered devices listed for Galen Robotics include Galen ES Cooperative Surgical Assistant Platform, Galen ES.