K250432
- 510(k) number
- K250432
- Device name
- Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-05-15
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K250432.pdf
Official FDA record: K250432
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.