Urosurge, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Urosurge, Inc. makes
Urosurge, Inc. manufactures ureteral stents, including the SpiralFlo, SpiraStent Plus, and Filastent, designed for urinary drainage and obstruction management. The company also produces the Percutaneous Sans (Stoller Afferent Nerve Stimulator) device, intended for nerve stimulation applications in urological procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Urosurge Spiralflo Ureteral Stent Ref K992391
Regimes: 510(k) Registry: 510(k)Urosurge Spirastent Plus Ureteral Stent Ref K981489
Regimes: 510(k) Registry: 510(k)Urosurge Filastent Ureteral Stent Ref K981491
Regimes: 510(k) Registry: 510(k)- Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Urosurge, Inc. have in the registry?
The registry currently lists 4 devices for Urosurge, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urosurge, Inc.'s devices?
Among its 4 most recently registered devices, Urosurge, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Urosurge, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Urosurge, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urosurge, Inc. in the registry?
The most recently registered devices listed for Urosurge, Inc. include UROSURGE SPIRALFLO URETERAL STENT, UROSURGE SPIRASTENT PLUS URETERAL STENT, UROSURGE FILASTENT URETERAL STENT and UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE.