Five Star Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Five Star Medical, Inc. makes
Five Star Medical, Inc. manufactures flexible endoscopes, including bronchoscopes designed for diagnostic and therapeutic procedures in the respiratory tract. These devices are intended for visual inspection and intervention within the bronchial passages.
The company’s portfolio is regulated under FDA’s Class II device classification, with products listed via the 510(k) pathway. These devices are registered in the U.S. market under FDA regulations.
Catalogue
5 Star Medical Endoscope Ref K963354
Regimes: 510(k) Registry: 510(k)Five Star Bronchoscope Ref K960876
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Five Star Medical, Inc. have in the registry?
The registry currently lists 2 devices for Five Star Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Five Star Medical, Inc.'s devices?
Among its 2 most recently registered devices, Five Star Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Five Star Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Five Star Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Five Star Medical, Inc. in the registry?
The most recently registered devices listed for Five Star Medical, Inc. include 5 STAR MEDICAL ENDOSCOPE and FIVE STAR BRONCHOSCOPE.