K231497
- 510(k) number
- K231497
- Device name
- Choledochoscope System
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd. CN
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-03-06
- Date received
- 2023-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231497.pdf
Official FDA record: K231497
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.