Company ยท US
Uroviu Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2025 | K253226 | UV5000W Handle Uroviu Corporation | FAJ |
| Sep 11, 2025 | K250797 | UV5000 Handle Uroviu Corporation | FAJ |
| Dec 13, 2024 | K243196 | Uro-G HD Cystoscope (1520) Uroviu Corporation | FAJ |
| Jun 7, 2024 | K232837 | Uro-G HD Flexible Cystoscope Uroviu Corporation | FAJ |
| May 4, 2021 | K202921 | Uro-G Cystoscope Uroviu Corporation | FAJ |
| Jul 2, 2019 | K182876 | Uro-N Cystoscope Uroviu Corporation | FAJ |
| Jan 30, 2018 | K171500 | Uro-V Cystoscope Uroviu Corporation | FAJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||