510(k) K203450 ยท EOX Esophagoscope (Flexible Or Rigid)
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
| Applicant | Capnostics, LLC, Concord NC, US |
| Decision | Substantially Equivalent, May 4, 2021 |
| Received | Nov 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203450
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2024 | Lucid Diagnostics, Inc. Brand Name: EsophaCap
Product Name: EsophaCap (20mm diameter, 20 pores/inch)
Model/Catalog Number: EC20T20VI
Software Version: N/A
Product Description: EsophaCap is pouched as individual units. 10 un Open, Classified |
EOX | None listed |
| May 24, 2024 | Lucid Diagnostics, Inc. Brand Name: EsophaCap
Product Name: EsophaCap (25mm diameter, 10 pores/inch)
Model/Catalog Number: EC25T10VI
Software Version: N/A
Product Description: EsophaCap is pouched as individual units. 10 un Open, Classified |
EOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.