510(k) K251204 ยท FDA Enteroscope And Accessories
FUJIFILM Stiffening Wire Device (SW-2000)
| Applicant | FUJIFILM Healthcare Americas Corporation, Lexington MA, US |
| Decision | Substantially Equivalent, Sep 26, 2025 |
| Received | Apr 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251204
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.