K253568
- 510(k) number
- K253568
- Device name
- Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
- Applicant
- Fujifilm Corporation JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-02-06
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253568.pdf
Official FDA record: K253568
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.