K251859
- 510(k) number
- K251859
- Device name
- EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- ODG — Endoscopic Ultrasound System, Gastroenterology-Urolo
- Decision date
- 2025-10-03
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K251859.pdf
Official FDA record: K251859
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.