K251867
- 510(k) number
- K251867
- Device name
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- Applicant
- Olympus Medical Systems Corp. JP
- Product code
- FDT — Duodenoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-09-19
- Date received
- 2025-06-17
- 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: K251867.pdf
Official FDA record: K251867
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.