K262552
- 510(k) number
- K262552
- Device name
- Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- Applicant
- Scivita Medical Technology Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-08-14
- Date received
- 2026-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K262552.pdf
Official FDA record: K262552
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.