K243261
- 510(k) number
- K243261
- Device name
- FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
- Applicant
- Fujifilm Corporation JP
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-05-23
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243261.pdf
Official FDA record: K243261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.