K251204
- 510(k) number
- K251204
- Device name
- FUJIFILM Stiffening Wire Device (SW-2000)
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- FDA — Enteroscope And Accessories
- Decision date
- 2025-09-26
- Date received
- 2025-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K251204.pdf
Official FDA record: K251204
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.