Syntheon, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Syntheon, LLC makes
Syntheon, LLC manufactures endoscopes with shaft diameters ranging from 11.3mm to 13.3mm, including the ENOLOK-FOR and PEL models. The company also produces the LAA Exclusion System and a corresponding LAA Selection Guide.
The company is based in the United States, and its portfolio includes Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
LAA Exclusion System Ref K232295
510(k) 510(k)
Frequently asked questions
How many devices does Syntheon, LLC have in the registry?
The registry currently lists 3 devices for Syntheon, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syntheon, LLC's devices?
Among its 3 most recently registered devices, Syntheon, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Syntheon, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Syntheon, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Syntheon, LLC in the registry?
The most recently registered devices listed for Syntheon, LLC include ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT, MODEL PEL, Syntheon LAA Exclusion System, Syntheon LAA Selection Guide and LAA Exclusion System.