K232837
- 510(k) number
- K232837
- Device name
- Uro-G HD Flexible Cystoscope
- Applicant
- Uroviu Corporation CA · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-06-07
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 4.3 MB · U.S. public domain
Also available from FDA: K232837.pdf
Official FDA record: K232837
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.