510(k) K223295 ยท FDA Enteroscope And Accessories
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
| Applicant | Fujifilm Corporaton, Ashigara Kami-Gun, JP |
| Decision | Substantially Equivalent, Jan 11, 2023 |
| Received | Oct 26, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223295
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.