Fem Suite, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Fem Suite, LLC makes
Fem Suite, LLC manufactures obstetric and ophthalmic surgical instruments, including the FEMTEN Cervical Tenaculum—a device used for uterine manipulation during gynecological procedures—and the FEMEYE Two, an ophthalmic instrument designed for retinal or anterior segment surgeries.
These products are classified as Class II medical devices under FDA regulations and are recorded in the FDA 510(k) database. The company is based in the United States.
Catalogue
Femten Cervical Tenaculum Ref K062563
Regimes: 510(k) Registry: 510(k)Femeye Two Ref K093218
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fem Suite, LLC have in the registry?
The registry currently lists 2 devices for Fem Suite, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fem Suite, LLC's devices?
Among its 2 most recently registered devices, Fem Suite, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Fem Suite, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fem Suite, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fem Suite, LLC in the registry?
The most recently registered devices listed for Fem Suite, LLC include FEMTEN CERVICAL TENACULUM and FEMEYE TWO.