# Uroviu Corporation

- Location (FDA's records): Los Altos, CA
- FDA decisions: 7 (2018–2025): 7 510(k) clearances
- Product codes: FAJ (7)
- 510(k) review time since 2016: median 199 days, against 129 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)

## Its most-cited devices
- K171500: Uro-V Cystoscope (2018), cited by 2
- K232837: Uro-G HD Flexible Cystoscope (2024), cited by 2
- K202921: Uro-G Cystoscope (2021), cited by 1

## Recent decisions
- K253226: UV5000W Handle (Oct 23, 2025)
- K250797: UV5000 Handle (Sep 11, 2025)
- K243196: Uro-G HD Cystoscope (1520) (Dec 13, 2024)
- K232837: Uro-G HD Flexible Cystoscope (Jun 7, 2024)
- K202921: Uro-G Cystoscope (May 4, 2021)
- K182876: Uro-N Cystoscope (Jul 2, 2019)
- K171500: Uro-V Cystoscope (Jan 30, 2018)

Source page: https://510kreport.com/company/uroviu