EsoCheck Cell Collection Device

FDA 510(k) K210137 · Lucid Diagnostics, Inc.

Unknown

510(k) numberK210137

Submission

Device name
EsoCheck Cell Collection Device
Applicant
Lucid Diagnostics, Inc.
New York, NY, US
Received
January 19, 2021
Decision date
February 18, 2021
Decision
Unknown (SESK)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EOX – Esophagoscope (Flexible Or Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4710
Specialty
Ear, Nose, Throat

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code EOX

510(k)DeviceApplicantDecision
K233142EndoSign® Cell collection device (ES-CYT-102)EOX · Traditional Cyted Limited01/19/2024SE
K230339EsoCheck Cell Collection DeviceEOX · Special Lucid Diagnostics, Inc.02/24/2023SESK
K223072PENTAX Medical Video Esophagoscope EE17-J10EOX · Traditional Pentax of America, Inc.12/02/2022SE
K222366EsoCheck Cell Collection DeviceEOX · Traditional Lucid Diagnostics, Inc.10/26/2022SESK
K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)EOX · Traditional Capnostics, LLC05/04/2021SE
K192523CMOS Video Esophagoscope SSUEOX · Traditional Karl Storz SE & CO. KG01/24/2020SE
K183262EsoCheck CCD Cell Collection DeviceEOX · Traditional Lucid Diagnostics, Inc.06/21/2019SESK
K182159Strome-Blitzer Cytology BalloonEOX · Traditional Adn International, LLC06/13/2019SE
K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorEOX · Traditional Cogentix Medical, Inc.11/15/2018SE
K181020Cytosponge Cell Collection DeviceEOX · Traditional Covidien, LLC08/16/2018SE

More from Covidien, LLC

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

Questions and answers

When was EsoCheck Cell Collection Device cleared by the FDA?

EsoCheck Cell Collection Device (K210137) received a 510(k) decision of Unknown on February 18, 2021, 30 days after the submission was received.

What is the product code of K210137?

The FDA product code is EOX – Esophagoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4710.