Sinusys Corporation
United StatesFDA applicant, unverified
- Devices
- 2
What Sinusys Corporation makes
Sinusys Corporation manufactures the VENT-OS Sinus Dilation System and its associated Vent-Os Sinus Dilation family, which are designed for sinus dilation procedures. These devices are intended to provide access and expansion within sinus cavities for medical interventions.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The portfolio is regulated under US FDA standards, and the manufacturer is based in the United States.
Catalogue
Vent-Os Sinus Dilation System Ref K133016
Regimes: 510(k) Registry: 510(k)Vent-Os Sinus Dilation family Ref K160770
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sinusys Corporation have in the registry?
The registry currently lists 2 devices for Sinusys Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sinusys Corporation's devices?
Among its 2 most recently registered devices, Sinusys Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Sinusys Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sinusys Corporation's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sinusys Corporation in the registry?
The most recently registered devices listed for Sinusys Corporation include VENT-OS SINUS DILATION SYSTEM and Vent-Os Sinus Dilation family.