510(k) K221452 ยท FDF Colonoscope And Accessories, Flexible/Rigid
DiLumen C1, EZ1 and Tool Mount
| Applicant | Lumendi, LLC, Westport CT, US |
| Decision | Substantially Equivalent, Feb 10, 2023 |
| Received | May 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221452
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.