Hutom, Inc.
South KoreaFDA applicant, unverified FDA FEI 3045817397
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Hutom, Inc. makes
Hutom, Inc. manufactures the RUS, a medical device designed for radiofrequency ablation procedures, used primarily in interventional radiology and cardiology to treat arrhythmias or tumors by delivering controlled thermal energy to targeted tissues.
The RUS is classified as a Class II device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Rus Ref K233457
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3045817397
- Address
- 6F, 279, Dongmak-ro, Mapo-gu, Seoul
Frequently asked questions
How many devices does Hutom, Inc. have in the registry?
The registry currently lists 1 device for Hutom, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hutom, Inc.'s devices?
Among its 1 most recently registered device, Hutom, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Hutom, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hutom, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hutom, Inc. in the registry?
The most recently registered devices listed for Hutom, Inc. include RUS.