Data / Medical devices / United States / Uro-1, Inc.
Uro-1, Inc.: FDA-registered device maker in Greensboro, NC, United States, 4 510(k) clearances
Uro-1, Inc. is registered with the FDA (registration 3027269340) in Greensboro, NC, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027269340
- Address
- 3703 Alliance Drive Suite A, Greensboro, NC, United States, 27407
- Owner or operator
- Uro1 Medical, Inc. (10087857)
- Roles
- Manufacturer
- First device listed
- April 20, 2023
- Registered through
- 2026
- Brand names listed
- Repris, SUREcore Plus, SUREcore Prime, SUREcore needle, coreCARE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Manufacturer | accessdata.fda.gov |
| Gastroenterology-Urology Accessories To A Biopsy Instrument | QFZ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2023 | K230646 | SUREcore Prime Biopsy Instrument | KNW | Substantially Equivalent | Uro-1 Medical, Inc. | accessdata.fda.gov |
| December 2, 2022 | K220611 | SUREcore Plus Biopsy Instrument | KNW | Substantially Equivalent | Uro-1, Inc. | accessdata.fda.gov |
| January 15, 2021 | K201650 | VMCore Biopsy Needle | KNW | Substantially Equivalent | Uro-1, Inc. | accessdata.fda.gov |
| May 3, 2018 | K180214 | Repris Bladder Injection System | FBK | Substantially Equivalent | Uro-1, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Gastroenterology-Urology Accessories To A Biopsy Instrument
- All makers of Instrument, Biopsy
Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.