Sonostik, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Sonostik, LLC makes
Sonostik, LLC manufactures guide wire introducers designed for vascular access procedures, including the SonoStik Guide Wire Introducer and SonoStik IV Guide Wire Introducer. These devices are intended to facilitate the insertion of guide wires in medical procedures requiring controlled catheter placement.
The company’s products fall under FDA Class II devices and are authorised via the 510(k) pathway. The portfolio is regulated under US medical device laws, with listings maintained in the FDA’s 510(k) database.
Catalogue
SonoStik Guide Wire Introducer Ref K243061
Regimes: 510(k) Registry: 510(k)SonoStik IV Guide Wire Introducer Ref K152177
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sonostik, LLC have in the registry?
The registry currently lists 2 devices for Sonostik, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sonostik, LLC's devices?
Among its 2 most recently registered devices, Sonostik, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Sonostik, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sonostik, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sonostik, LLC in the registry?
The most recently registered devices listed for Sonostik, LLC include SonoStik Guide Wire Introducer and SonoStik IV Guide Wire Introducer.