K250269
- 510(k) number
- K250269
- Device name
- Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- Applicant
- Ambu A/S DK
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-06-11
- Date received
- 2025-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250269.pdf
Official FDA record: K250269
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.