FDA.reportPublic FDA data

510(k) K230339

Device
EsoCheck Cell Collection Device
Applicant
Lucid Diagnostics, Inc.
510(k) number
K230339
Product code
EOX
Decision
Unknown (SESK)
Decision date
2023-02-24
Date received
2023-02-07
Regulation
874.4710
Classification name
Esophagoscope (Flexible Or Rigid)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Deepika Lakhani
Address
360 Madison Ave., Floor 25 New York NY US 10017 10017

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EOX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233142EndoSign® Cell collection device (ES-CYT-102)Cyted Limited2024-01-19
K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.2022-12-02
K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.2022-10-26
K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLC2021-05-04
K210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.2021-02-18
K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG2020-01-24
K183262EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc.2019-06-21
K182159Strome-Blitzer Cytology BalloonAdn International, LLC2019-06-13
K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.2018-11-15
K181020Cytosponge Cell Collection DeviceCovidien, LLC2018-08-16
K152794Cytosponge Cell Collection DeviceCovidien, LLC2016-04-12
K142695Cytosponge Cell Collection DeviceCovidien, LLC2014-11-26
K131131E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMIntromedic Co., Ltd.2013-06-21
K120702E.G. SCAN II ESPHAGOSCOPE SYSTEMIntromedic Co., Ltd.2012-06-20
K111030E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEMIntromedic Co., Ltd.2011-10-21