Company ยท US
Lucid Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 2023 | K230339 | EsoCheck Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| Oct 26, 2022 | K222366 | EsoCheck Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| Feb 18, 2021 | K210137 | EsoCheck Cell Collection Device Lucid Diagnostics, Inc. | EOX |
| Jun 21, 2019 | K183262 | EsoCheck CCD Cell Collection Device Lucid Diagnostics, Inc. | EOX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K203450 |
| 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 | K203450 |