EsoCheck Cell Collection Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230339 FDA 510(k)
- FDA Product Code
- EOX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4710 FDA 510(k)
- Regulation Number
- 874.4710 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The EsoCheck Cell Collection Device is a non-endoscopic, single-use diagnostic tool designed for collecting esophageal cells. Classified as an esophagoscope (flexible or rigid) under FDA regulation 874.4710, it facilitates cellular sampling without invasive endoscopic procedures, enabling non-invasive esophageal analysis.
Supplied as a sterile, single-use disposable device, the EsoCheck is intended for use in clinical settings for esophageal cell retrieval. It is regulated under FDA 510(k) clearance (K230339) and falls under Class II medical device classification. The device is packaged for one-time use and requires no special storage conditions beyond standard medical device handling.
Frequently asked questions
What is the EsoCheck Cell Collection Device used for in clinical practice?
The EsoCheck Cell Collection Device is designed for non-invasive collection of esophageal cells, eliminating the need for traditional endoscopic procedures. It is intended for clinical use in retrieving cells from the esophagus to enable further diagnostic analysis, such as detecting abnormalities like dysplasia or cancer without the invasiveness of an esophagoscope.
Is the EsoCheck Cell Collection Device reusable or single-use, and how should it be stored?
The EsoCheck is a sterile, single-use device, meaning it is intended for one-time use only. Storage requires standard medical device handling—no special conditions are specified, so it can be kept in a clean, dry environment until use, following general medical device storage guidelines.
What regulatory pathway does the EsoCheck Cell Collection Device follow, and who is the manufacturer?
The EsoCheck was cleared via an FDA 510(k) pathway under the classification of an esophagoscope (flexible or rigid) and falls under Class II medical device regulations. It was submitted by Lucid Diagnostics, Inc. and received clearance with the K230339 number. The device is regulated under FDA code 874.4710 and is intended for use in the Ear, Nose, and Throat specialty.
Are there different sizes or models of the EsoCheck Cell Collection Device available?
The provided data does not specify distinct sizes or models of the EsoCheck, but it is classified as a non-endoscopic, single-use device for esophageal cell collection. If multiple registration numbers are listed, they may correspond to variations in packaging or lot numbers rather than functional differences. For precise sizing or model details, consult the manufacturer’s product documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EsoCheck - luciddx.com, Lucid Diagnostics Chairman & CEO, Dr. Lishan Aklog, Highlights EsoCheck ..., EsoCheck CCD Cell Collection Device — FDA Class II Medical Device ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230339 | Class II | Active |
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Manufacturer
- Manufacturer
- Lucid Diagnostics, Inc.
Sources (1)
- FDA 510(k) K230339 24 fields · synced Sep 19, 2026