Medstone Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Medstone Intl., Inc. makes
Medstone Intl., Inc. manufactures extracorporeal shock wave lithotripters, including the STS-T and STS models, designed for breaking kidney and urinary stones. Their UroPro 2000 system with tomographic imaging and fluoroscopic modules supports precise stone localization and treatment. These devices are used in urological procedures to fragment calculi without invasive surgery.
The company’s shock wave lithotripters fall under FDA-regulated Class II and Class III devices, with some models authorised via the 510(k) pathway and others through the Premarket Approval (PMA) process. Their products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Sts-T Lithotripter, Model Sts-T Ref K010900
Regimes: 510(k) Registry: 510(k)Medstone, Uropro 2000, Tomographic Option Ref K013620
Regimes: 510(k) Registry: 510(k)Sts(Tm) Fluoroscopic Imaging Module Ref K905278
Regimes: 510(k) Registry: 510(k)Medstone Sts Lithotripter Ref P970042
Regimes: PMA, withdrawn Registry: PMA- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Medstone Intl., Inc. have in the registry?
The registry currently lists 5 devices for Medstone Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medstone Intl., Inc.'s devices?
Among its 5 most recently registered devices, Medstone Intl., Inc. has devices listed in FDA 510(k) (3 devices) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medstone Intl., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Medstone Intl., Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Medstone Intl., Inc. in the registry?
The most recently registered devices listed for Medstone Intl., Inc. include STS-T LITHOTRIPTER, MODEL STS-T, MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION, STS(TM) FLUOROSCOPIC IMAGING MODULE and MEDSTONE STS LITHOTRIPTER.