Femcap Incorporated
Country not established
- Devices
- 2
What Femcap Incorporated makes
Femcap Incorporated manufactures barrier contraceptive devices, including the FEMMYCYCLE and the FEMCAP CONTRACEPTIVE BARRIER DEVICE, designed for vaginal use to prevent pregnancy. These products are intended for single-use and are positioned as non-hormonal alternatives for contraception.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with some products authorised through the 510(k) pathway and others via Premarket Approval (PMA). These devices are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
Catalogue
Femmycycle Ref K121857
Regimes: 510(k) Registry: 510(k)Femcap Contraceptive Barrier Device Ref P020041
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Femcap Incorporated have in the registry?
The registry currently lists 2 devices for Femcap Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Femcap Incorporated's devices?
Among its 2 most recently registered devices, Femcap Incorporated has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Femcap Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Femcap Incorporated's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Femcap Incorporated in the registry?
The most recently registered devices listed for Femcap Incorporated include FEMMYCYCLE and FEMCAP CONTRACEPTIVE BARRIER DEVICE.