K250550
- 510(k) number
- K250550
- Device name
- FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- Applicant
- Fujifilm Corporation JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-02-17
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250550.pdf
Official FDA record: K250550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.