K241444
- 510(k) number
- K241444
- Device name
- Biliary Pancreaticobiliary Scope System
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd. CN
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-01-21
- Date received
- 2024-05-22
- 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: K241444.pdf
Official FDA record: K241444
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.