Gyrus Ent LLC
United StatesFDA applicant, unverified
- Devices
- 28
What Gyrus Ent LLC makes
Gyrus Ent LLC manufactures medical devices for ear, nose, and throat (ENT) procedures, including fluoroplastic ventilation tubes for airway management, nerve stimulators for surgical guidance, and titanium tube systems for transcutaneous hearing aids. Their portfolio also includes irrigation pumps for ENT surgeries, modular prostheses for ear reconstruction, and thermal scalpels for precise tissue control. Additional offerings cover hearing aid components like piston prostheses and incus-stapes implants, as well as universal long implants for otologic applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance for market authorisation. Products are listed in the FDA’s 510(k) registry, reflecting their compliance with US regulatory requirements. The manufacturer operates from the United States, adhering to domestic medical device standards.
Catalogue
Search and filter all 28 devicesFrequently asked questions
How many devices does Gyrus Ent LLC have in the registry?
The registry currently lists 28 devices for Gyrus Ent LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gyrus Ent LLC's devices?
Among its 28 most recently registered devices, Gyrus Ent LLC has devices listed in FDA 510(k) (28 devices).
What risk classes do Gyrus Ent LLC's devices fall under?
Among its 28 most recently registered devices, the classes recorded for Gyrus Ent LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gyrus Ent LLC in the registry?
The most recently registered devices listed for Gyrus Ent LLC include FLUOROPLASTIC VENTILATION TUBES, GYRUS ENT NERVE STIMULATOR, RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM and MODULAR PORP AND TORP MODEL TBD.