510(k) K261400 · FDS Gastroscope And Accessories, Flexible/Rigid
Ambu® aScope Gastro; Ambu® aScope Gastro Large
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | Apr 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261400
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.