Cycle Clarity
Country not established FDA FEI 3024972425
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Cycle Clarity makes
Cycle Clarity manufactures Follicle Clarity, a medical imaging device designed for transvaginal ultrasound evaluation of ovarian follicles during fertility treatments. The system is intended for obstetric and gynecological use to monitor follicular development and guide assisted reproductive procedures.
The company’s portfolio is regulated under Class II devices in the United States, with Follicle Clarity authorised via the FDA’s 510(k) pathway. The device is listed in the FDA’s 510(k) database, and the manufacturer operates from the US.
Catalogue
- GUDID
Follicle Clarity Ref K212012
510(k) 510(k)
Company details
- FDA FEI number
- 3024972425
- Address
- 1209 Fifteen Mile Landing Rd., Awendaw, SC, 29429
Frequently asked questions
How many devices does Cycle Clarity have in the registry?
The registry currently lists 2 devices for Cycle Clarity. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cycle Clarity's devices?
Among its 2 most recently registered devices, Cycle Clarity has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cycle Clarity's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cycle Clarity's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cycle Clarity in the registry?
The most recently registered devices listed for Cycle Clarity include Follicle Clarity 6.12.01 and Follicle Clarity.