K233321
- 510(k) number
- K233321
- Device name
- Double Balloon Endoscope EN-840T, Over-tube TS-1214C
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- FDA — Enteroscope And Accessories
- Decision date
- 2024-06-13
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233321.pdf
Official FDA record: K233321
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.