X-Sten Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What X-Sten Corp. makes
X-Sten Corp. manufactures surgical tools and device kits designed for mild procedures, including the X-STEN MILD TOOL KIT (MTK-0001) and the Vertos Medical MILD Device Kit. These products are intended for controlled tissue manipulation in minimally invasive applications.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
X-Sten Mild Tool Kit, Model Mtk-0001 Ref K062038
510(k) 510(k)Vertos Medical Mild Device Kit Ref K093062
510(k) 510(k)
Frequently asked questions
How many devices does X-Sten Corp. have in the registry?
The registry currently lists 2 devices for X-Sten Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list X-Sten Corp.'s devices?
Among its 2 most recently registered devices, X-Sten Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do X-Sten Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for X-Sten Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from X-Sten Corp. in the registry?
The most recently registered devices listed for X-Sten Corp. include X-STEN MILD TOOL KIT, MODEL MTK-0001 and VERTOS MEDICAL MILD DEVICE KIT.