K243196
- 510(k) number
- K243196
- Device name
- Uro-G HD Cystoscope (1520)
- Applicant
- Uroviu Corporation CA · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-12-13
- Date received
- 2024-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K243196.pdf
Official FDA record: K243196
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.