K251861
- 510(k) number
- K251861
- Device name
- FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
- Applicant
- Fujifilm Corporation JP
- Product code
- FDT — Duodenoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-03-09
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251861.pdf
Official FDA record: K251861
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.