K243260
- 510(k) number
- K243260
- Device name
- FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
- Applicant
- Fujifilm Corporation JP
- Product code
- FET — Endoscopic Video Imaging System/Component, Gastroent
- Decision date
- 2025-04-11
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K243260.pdf
Official FDA record: K243260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.