Sontina Medical, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Sontina Medical, LLC makes
Sontina Medical, LLC manufactures the PRESTO Breast Biopsy Device, a system designed for minimally invasive breast tissue sampling and diagnostic procedures.
The PRESTO Breast Biopsy Device is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Presto Breast Biopsy Device Ref K120440
Regimes: 510(k) Registry: 510(k)Presto Breast Biopsy Device Ref K133702
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sontina Medical, LLC have in the registry?
The registry currently lists 2 devices for Sontina Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sontina Medical, LLC's devices?
Among its 2 most recently registered devices, Sontina Medical, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Sontina Medical, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sontina Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sontina Medical, LLC in the registry?
The most recently registered devices listed for Sontina Medical, LLC include PRESTO BREAST BIOPSY DEVICE.