K242779
- 510(k) number
- K242779
- Device name
- Hood (DH-083ST)
- Applicant
- Fujifilm Corporation JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-10-11
- Date received
- 2024-09-13
- 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: K242779.pdf
Official FDA record: K242779
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.