Roen Surgical, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Zamenix™ P Ref K253505
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roen Surgical, Inc. have in the registry?
The registry currently lists 1 device for Roen Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roen Surgical, Inc.'s devices?
Among its 1 most recently registered device, Roen Surgical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Roen Surgical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Roen Surgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roen Surgical, Inc. in the registry?
The most recently registered devices listed for Roen Surgical, Inc. include Zamenix™ P.