Ent Biotech Solutions
Country not established
- Devices
- 1
What Ent Biotech Solutions makes
Ent Biotech Solutions manufactures the ELASSO, a tissue removal device designed for endoscopic sinus surgery. This device is intended for precise excision and removal of tissue within the nasal and sinus cavities, aiding in procedures such as sinus surgery and polyp removal.
The ELASSO is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ent Biotech Solutions have in the registry?
The registry currently lists 1 device for Ent Biotech Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ent Biotech Solutions's devices?
Among its 1 most recently registered device, Ent Biotech Solutions has devices listed in FDA 510(k) (1 device).
What risk classes do Ent Biotech Solutions's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ent Biotech Solutions's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ent Biotech Solutions in the registry?
The most recently registered devices listed for Ent Biotech Solutions include ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO).