K243512
- 510(k) number
- K243512
- Device name
- FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- Applicant
- Fujifilm Corporation JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-06-10
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K243512.pdf
Official FDA record: K243512
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.