Carbylan Biosurgery
Country not established
- Devices
- 2
What Carbylan Biosurgery makes
Carbylan Biosurgery manufactures sinus-related medical devices, including a bioabsorbable gel and stent system designed for nasal passage support and sinus cavity management. The products are intended for temporary structural reinforcement and tissue integration within sinus anatomy.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the 510(k) clearance registry. These devices are regulated under the US Food and Drug Administration’s jurisdiction, adhering to applicable 510(k) premarket notification requirements.
Catalogue
Advacoat Sinus Gel And Stent Ref K070496
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Carbylan Biosurgery have in the registry?
The registry currently lists 2 devices for Carbylan Biosurgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carbylan Biosurgery's devices?
Among its 2 most recently registered devices, Carbylan Biosurgery has devices listed in FDA 510(k) (2 devices).
What risk classes do Carbylan Biosurgery's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Carbylan Biosurgery's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Carbylan Biosurgery in the registry?
The most recently registered devices listed for Carbylan Biosurgery include ADVACOAT SINUS GEL AND STENT and ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200.