510(k) K152794 ยท EOX Esophagoscope (Flexible Or Rigid)
Cytosponge Cell Collection Device
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 12, 2016 |
| Received | Sep 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152794
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2016 | Covidien, LLC Covidien Cytosponge Cell Collection Kit.
Contains Cytosponge Cell Collection Device, Specimen Jar with preservative.
Item code CYTO-KIT-R
Gastroenterology: Cytosponge Cell Collection Device is indic Terminated |
EOX | None listed |
| Jun 6, 2016 | Covidien, LLC Covidien Cytosponge Cell Collection Device.
Item code CYTO-101-01.
Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the e Terminated |
EOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.