Bevan Medical, Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Bevan Medical, Inc. makes
Bevan Medical, Inc. manufactures disposable incontinence briefs and incontinence management systems designed for adult use, including the UNITY Disposable Incontinent Brief and the ESTEEM Incontinent System. These products are intended for short- to long-term wear to absorb and contain urinary or fecal incontinence.
The company’s portfolio is classified under FDA’s Class I medical devices, which are subject to general controls and may require a 510(k) premarket notification submission. These products are listed with the FDA under the 510(k) pathway, and the company is based in the United States.
Catalogue
Unity Disposable Incontinent Brief Ref K860459
Regimes: 510(k) Registry: 510(k)Esteem Incontinent System Ref K852276
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bevan Medical, Inc. have in the registry?
The registry currently lists 2 devices for Bevan Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bevan Medical, Inc.'s devices?
Among its 2 most recently registered devices, Bevan Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bevan Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bevan Medical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bevan Medical, Inc. in the registry?
The most recently registered devices listed for Bevan Medical, Inc. include UNITY DISPOSABLE INCONTINENT BRIEF and ESTEEM INCONTINENT SYSTEM.