Class Class II
EsoCheck Cell Collection Device (K230339)
Description
EsoCheck Cell Collection Device by Lucid Diagnostics, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230339
Clearance Date2023-02-24
Clearance TypeSpecial
Product CodeEOX
Regulation Number874.4710
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230339
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EsoCheck Cell Collection Device (K230339) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022 |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed fr... | Capnostics, LLC | 2021 |
Trace the full predicate network for K230339
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.