K240374
- 510(k) number
- K240374
- Device name
- Ureterorenoscope System
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-05-10
- Date received
- 2024-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240374.pdf
Official FDA record: K240374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.