Cryopen, Inc.
Country not established
- Devices
- 1
What Cryopen, Inc. makes
Cryopen, Inc. manufactures the Cryopen Cryosurgical System, a device designed for controlled cryoablation procedures to treat tissue through extreme cold.
The company’s portfolio is regulated as Class II medical devices in the US, with the Cryopen Cryosurgical System authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Cryopen Cryosurgical System, K102214 Ref K110754
510(k) 510(k)
Frequently asked questions
How many devices does Cryopen, Inc. have in the registry?
The registry currently lists 1 device for Cryopen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cryopen, Inc.'s devices?
Among its 1 most recently registered device, Cryopen, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cryopen, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cryopen, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cryopen, Inc. in the registry?
The most recently registered devices listed for Cryopen, Inc. include CRYOPEN CRYOSURGICAL SYSTEM, K102214.