Lucid Diagnostics, Inc.

Medical device manufacturer in Foxboro, MA.

4510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K230339EsoCheck Cell Collection DeviceEOX · Special 02/24/2023SESK
K222366EsoCheck Cell Collection DeviceEOX · Traditional 10/26/2022SESK
K210137EsoCheck Cell Collection DeviceEOX · Special 02/18/2021SESK
K183262EsoCheck CCD Cell Collection DeviceEOX · Traditional 06/21/2019SESK

Recalls

RecallProductInitiated
Z-1900-2024 Class IIBrand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)…The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from… 04/24/2024Open, Classified
Z-1899-2024 Class IIBrand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)…The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from… 04/24/2024Open, Classified