K232919
- 510(k) number
- K232919
- Device name
- Ambu® aScope Gastro Large; Ambu® aBox 2
- Applicant
- Ambu A/S DK
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-04-05
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232919.pdf
Official FDA record: K232919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.