Fulwell LLC
Country not established FDA establishment FEI 3010131466
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
What Fulwell LLC makes
Fulwell LLC manufactures RF surgical generators and electrosurgical generators, which are used in minimally invasive and open surgical procedures to cut tissue and coagulate blood vessels.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Fulwell LLC is based in the United States.
Catalogue
RF Surgical Generator Ref K200931
510(k) 510(k)Electrosurgical Generator Ref K183564
510(k) 510(k)
Company details
- FDA FEI number
- 3010131466
- Address
- 3411 NW 48 STREET, Miami, FL, 33142
Frequently asked questions
How many devices does FULWELL LLC have in the registry?
The registry currently lists 2 devices for FULWELL LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list FULWELL LLC's devices?
Among its 2 most recently registered devices, FULWELL LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do FULWELL LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for FULWELL LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from FULWELL LLC in the registry?
The most recently registered devices listed for FULWELL LLC include RF Surgical Generator and Electrosurgical Generator.