K261880
- 510(k) number
- K261880
- Device name
- FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
- Applicant
- Fujifilm Corporation JP
- Product code
- FET — Endoscopic Video Imaging System/Component, Gastroent
- Decision date
- 2026-07-02
- Date received
- 2026-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K261880.pdf
Official FDA record: K261880
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.