K230332
- 510(k) number
- K230332
- Device name
- Ambu® aScope Colon; Ambu® aBox 2
- Applicant
- Ambu A/S DK
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-09-15
- Date received
- 2023-02-07
- 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: K230332.pdf
Official FDA record: K230332
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.