Pelvalon, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Pelvalon, Inc. makes
Pelvalon, Inc. manufactures the Eclipse System, a medical device designed for the treatment of urinary incontinence in women through neuromodulation therapy.
The Eclipse System 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
Eclipse System Ref DEN140020
Regimes: De Novo Registry: De NovoEclipse System Ref K150558
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pelvalon, Inc. have in the registry?
The registry currently lists 2 devices for Pelvalon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pelvalon, Inc.'s devices?
Among its 2 most recently registered devices, Pelvalon, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pelvalon, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pelvalon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pelvalon, Inc. in the registry?
The most recently registered devices listed for Pelvalon, Inc. include ECLIPSE SYSTEM.