K260516
- 510(k) number
- K260516
- Device name
- BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- Applicant
- MacroLux Medical Technology Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-07-20
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260516.pdf
Official FDA record: K260516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.