Uro-1, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 3027269340
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Uro-1, Inc. makes
Uro-1, Inc. manufactures biopsy instruments and bladder treatment systems, including the SUREcore Plus Biopsy Instrument for tissue sampling and the Repris Bladder Injection System for intravesical procedures. The VMCore Biopsy Needle is designed for precise tissue acquisition in urological applications.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- GUDID
- GUDID
SUREcore Plus Biopsy Instrument Ref K220611
510(k) 510(k)Repris Bladder Injection System Ref K180214
510(k) 510(k)VMCore Biopsy Needle Ref K201650
510(k) 510(k)
Company details
- FDA FEI number
- 3027269340
- DUNS number
- 082407801
- Address
- 3703 Alliance Drive, Greensboro, NC, 27407
- [email protected]
- Phone
- 3369305464
Frequently asked questions
How many devices does Uro-1, Inc. have in the registry?
The registry currently lists 5 devices for Uro-1, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Uro-1, Inc.'s devices?
Among its 5 most recently registered devices, Uro-1, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Uro-1, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Uro-1, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Uro-1, Inc. in the registry?
The most recently registered devices listed for Uro-1, Inc. include SUREcore Plus Biopsy Instrument SP-LA18-22, SUREcore Plus Biopsy Instrument SP-LA18-25, SUREcore Plus Biopsy Instrument and Repris Bladder Injection System.