510(k) K210851 ยท FDF Colonoscope And Accessories, Flexible/Rigid
DiLumen Endolumenal Interventional Platform (DiLumen)
| Applicant | Lumendi, LLC, Westport CT, US |
| Decision | Substantially Equivalent, Apr 21, 2021 |
| Received | Mar 22, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210851
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.