Zutron Medical, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Zutron Medical, LLC makes
Zutron Medical, LLC manufactures the ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003, a device designed to test endoscopes for leaks during cleaning and sterilization processes.
The endoscope leak tester is classified as a Class I medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Zutron Colonoscope Stiffening Device Ref K051068
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Zutron Medical, LLC have in the registry?
The registry currently lists 2 devices for Zutron Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zutron Medical, LLC's devices?
Among its 2 most recently registered devices, Zutron Medical, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Zutron Medical, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Zutron Medical, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zutron Medical, LLC in the registry?
The most recently registered devices listed for Zutron Medical, LLC include ZUTRON COLONOSCOPE STIFFENING DEVICE and ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003.