K240849
- 510(k) number
- K240849
- Device name
- Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
- Applicant
- Ambu A/S DK
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-10-16
- Date received
- 2024-03-27
- 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: K240849.pdf
Official FDA record: K240849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.