K230475
- 510(k) number
- K230475
- Device name
- Medical Video Endoscope System
- Applicant
- Huger Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2023-11-03
- Date received
- 2023-02-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230475.pdf
Official FDA record: K230475
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.