K231774
- 510(k) number
- K231774
- Device name
- CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
- Applicant
- MacroLux Medical Technology Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-01-11
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K231774.pdf
Official FDA record: K231774
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.