K233630
- 510(k) number
- K233630
- Device name
- Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2
- Applicant
- Ambu A/S DK
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-06-24
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233630.pdf
Official FDA record: K233630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.