Karl Storz Lithotripsy-America, Inc.
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- Devices
- 1
What Karl Storz Lithotripsy-America, Inc. makes
Karl Storz Lithotripsy-America, Inc. manufactures the Modulith Lithotripsy system (Model SLK), a medical device designed for the fragmentation of urinary and upper ureteral calculi (kidney and ureter stones) using extracorporeal shockwave lithotripsy (ESWL).
The Modulith Lithotripsy system is classified as a Class II device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Modulith Lithotripsy, Model Slk For The Fragmentation Of Urinary And Upper Ureteral Calculi Ref K010340
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karl Storz Lithotripsy-America, Inc. have in the registry?
The registry currently lists 1 device for Karl Storz Lithotripsy-America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karl Storz Lithotripsy-America, Inc.'s devices?
Among its 1 most recently registered device, Karl Storz Lithotripsy-America, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Karl Storz Lithotripsy-America, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Karl Storz Lithotripsy-America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karl Storz Lithotripsy-America, Inc. in the registry?
The most recently registered devices listed for Karl Storz Lithotripsy-America, Inc. include MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI.