K240227
- 510(k) number
- K240227
- Device name
- LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
- Applicant
- Lina Medical Aps DK
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-08-22
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240227.pdf
Official FDA record: K240227
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.