K252598
- 510(k) number
- K252598
- Device name
- Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd. CN
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-09-15
- Date received
- 2025-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252598.pdf
Official FDA record: K252598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.