Lucid Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1900-2024 | Class II | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: | April 24, 2024 |
| Z-1899-2024 | Class II | Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: | April 24, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230339 | EsoCheck Cell Collection Device | February 24, 2023 |
| K222366 | EsoCheck Cell Collection Device | October 26, 2022 |
| K210137 | EsoCheck Cell Collection Device | February 18, 2021 |
| K183262 | EsoCheck CCD Cell Collection Device | June 21, 2019 |