K243091
- 510(k) number
- K243091
- Device name
- Over-tube (TR-1108A)
- Applicant
- Fujifilm Corporation JP
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2024-11-01
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243091.pdf
Official FDA record: K243091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.