K243535
- 510(k) number
- K243535
- Device name
- Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
- Applicant
- Shanghai SeeGen Photoelectric Technology Co., Ltd. CN
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-03-07
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243535.pdf
Official FDA record: K243535
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.