Uroviu Corporation: FDA clearances and approvals
Uroviu Corporation has 7 FDA 510(k) clearances (first 2018, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time: 217 days. Since 2017 its median was 217 days, against 140 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 252 |
| 2019 | 1 | 263 |
| 2020 | 0 | — |
| 2021 | 1 | 217 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 170 |
| 2025 | 2 | 102 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Uroviu Corporation's cleared 510(k)s took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 7 | 7 |
Review panels
Most recent Uroviu Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253226 | UV5000W Handle | FAJ | 2025-10-23 | 24 |
| K250797 | UV5000 Handle | FAJ | 2025-09-11 | 181 |
| K243196 | Uro-G HD Cystoscope (1520) | FAJ | 2024-12-13 | 73 |
| K232837 | Uro-G HD Flexible Cystoscope | FAJ | 2024-06-07 | 267 |
| K202921 | Uro-G Cystoscope | FAJ | 2021-05-04 | 217 |
| K182876 | Uro-N Cystoscope | FAJ | 2019-07-02 | 263 |
| K171500 | Uro-V Cystoscope | FAJ | 2018-01-30 | 252 |
Recalls
openFDA lists no recalls under a recalling firm named Uroviu Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Uroviu Corporation have?
Uroviu Corporation has 7 FDA 510(k) clearances (first 2018, latest 2025), across 1 product code in 1 review panel.
How long does FDA take to clear Uroviu Corporation's 510(k)s?
The median time from FDA receipt to decision across Uroviu Corporation's cleared 510(k)s is 217 days. Since 2017: 217 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does Uroviu Corporation make?
Its most frequent FDA product codes are FAJ (Cystoscope And Accessories, Flexible/Rigid, 7).
Has Uroviu Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Uroviu Corporation. Related entities may recall under other names.
Next steps
- See all 7 Uroviu Corporation clearances with predicates and recalls
- Run predicate analysis for product code FAJ, Uroviu Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.