K233752
- 510(k) number
- K233752
- Device name
- Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-05-02
- Date received
- 2023-11-22
- 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: K233752.pdf
Official FDA record: K233752
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.