K231105
- 510(k) number
- K231105
- Device name
- Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd. CN
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-10-17
- Date received
- 2023-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231105.pdf
Official FDA record: K231105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.