Ureteral Stent Company
Country not established
- Devices
- 2
What Ureteral Stent Company makes
The company manufactures ureteral stent kits designed for urinary drainage, including models with 6 French gauge shafts measuring 24cm and 26cm in length. These products are intended for temporary or permanent placement within the ureter to facilitate urine flow when obstruction or blockage occurs. The stents are supplied as part of a kit, likely including insertion tools and sterile packaging. Variations in length accommodate different anatomical requirements in patients.
The ureteral stent kits fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance through the FDA. These devices are listed under the 510(k) pathway, indicating they meet established standards for safety and effectiveness. The company operates within US regulatory frameworks, adhering to FDA requirements for medical device authorisation.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Ureteral Stent Company have in the registry?
The registry currently lists 2 devices for Ureteral Stent Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ureteral Stent Company's devices?
Among its 2 most recently registered devices, Ureteral Stent Company has devices listed in FDA 510(k) (2 devices).
What risk classes do Ureteral Stent Company's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ureteral Stent Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ureteral Stent Company in the registry?
The most recently registered devices listed for Ureteral Stent Company include RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm and RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm.