Urotec Systems Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Urotec Systems Corp. makes
Urotec Systems Corp. manufactures urinary catheters, including the Soft Silplastic Catheter for intermittent use, and closed irrigation syringes designed for bladder management procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Urotec/Franklin Soft Simplastic Catheter Ref K851684
Regimes: 510(k) Registry: 510(k)Urotec Closed Irrigatiion Syringe Ref K854625
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Urotec Systems Corp. have in the registry?
The registry currently lists 2 devices for Urotec Systems Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urotec Systems Corp.'s devices?
Among its 2 most recently registered devices, Urotec Systems Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Urotec Systems Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Urotec Systems Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urotec Systems Corp. in the registry?
The most recently registered devices listed for Urotec Systems Corp. include UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER and UROTEC CLOSED IRRIGATIION SYRINGE.