Cryogen, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Cryogen, Inc. makes
Cryogen, Inc. manufactures cryosurgical units and associated accessories, including systems designed for cardiac cryosurgery. These devices use controlled freezing to treat tissue, with dedicated systems tailored for specific surgical applications.
The company’s cryosurgical products are classified as Class II devices under FDA regulations and are authorised via the 510(k) pathway. They are based in the United States.
Catalogue
Cryosurgical Unit And Accessories Ref K003050
510(k) 510(k)Cryogen Cardiac Cryosurgical System Ref K974320
510(k) 510(k)Cryogen Cryosurgical System Ref K964971
510(k) 510(k)Cryogen Cryosurgical System Ref K972662
510(k) 510(k)
Frequently asked questions
How many devices does Cryogen, Inc. have in the registry?
The registry currently lists 4 devices for Cryogen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cryogen, Inc.'s devices?
Among its 4 most recently registered devices, Cryogen, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Cryogen, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cryogen, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cryogen, Inc. in the registry?
The most recently registered devices listed for Cryogen, Inc. include CRYOSURGICAL UNIT AND ACCESSORIES, CRYOGEN CARDIAC CRYOSURGICAL SYSTEM and CRYOGEN CRYOSURGICAL SYSTEM.