510(k) K181020 ยท EOX Esophagoscope (Flexible Or Rigid)
Cytosponge Cell Collection Device
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Aug 16, 2018 |
| Received | Apr 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2023 | Covidien, LLC Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM Open, Classified |
EOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.