K241639
- 510(k) number
- K241639
- Device name
- Single-use Video Ureterorenoscope (SVU-220US)
- Applicant
- Huger Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-07-01
- Date received
- 2024-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241639.pdf
Official FDA record: K241639
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.