K240663
- 510(k) number
- K240663
- Device name
- Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd. CN
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-06-21
- Date received
- 2024-03-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.0 MB · U.S. public domain
Also available from FDA: K240663.pdf
Official FDA record: K240663
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.