K243857
- 510(k) number
- K243857
- Device name
- Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-04-11
- Date received
- 2024-12-16
- 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: K243857.pdf
Official FDA record: K243857
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.