Ikonos Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Ikonos Corp. makes
Ikonos Corp. manufactures cranial clamps, including the Sevrain Cranial Clamp (SCC-200 Series and standard models), used in neurosurgical procedures for skull stabilization. The company also produces tympanostomy ventilation tubes, which are inserted into the eardrum to manage fluid buildup and improve hearing in pediatric and adult patients.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database. Ikonos Corp. is based in the United States.
Catalogue
Sevrain Cranial Clamp (Scc-200 Series) Ref K971408
Regimes: 510(k) Registry: 510(k)Sevrain Cranial Clamp Ref K971252
Regimes: 510(k) Registry: 510(k)Tympanostomy Ventilation Tube Ref K971454
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ikonos Corp. have in the registry?
The registry currently lists 3 devices for Ikonos Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ikonos Corp.'s devices?
Among its 3 most recently registered devices, Ikonos Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Ikonos Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ikonos Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ikonos Corp. in the registry?
The most recently registered devices listed for Ikonos Corp. include SEVRAIN CRANIAL CLAMP (SCC-200 SERIES), SEVRAIN CRANIAL CLAMP and TYMPANOSTOMY VENTILATION TUBE.