510(k) K183262
- Device
- EsoCheck CCD Cell Collection Device
- Applicant
- Lucid Diagnostics, Inc.
- 510(k) number
- K183262
- Product code
- EOX
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2019-06-21
- Date received
- 2018-11-23
- Regulation
- 874.4710
- Classification name
- Esophagoscope (flexible Or Rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lishan Aklog
- Address
- One Grand Central Pl., Suite 4600 New York NY US 10165 10165
FDA Registration Numbers#
- 3005465238
- 3003782610
- 3013684328
- 9611616
- 3006546082
- 3016490370
- 3008439484
- 3011137372
- 9610877
- 3014328942
- 9610617
- 1045254
- 3004904811
- 3010202439
- 3005382983
- 2020550
- 3007244127
- 9681572
- 3004180226
- 1048735
- 3003761012
- 3010041511
- 3023852420
- 3014342096
- 1221826
- 3012322232
- 3004644065
- 3015865915
- 9612501
- 3025482817
- 3018094310
- 2242464
- 3014605202
- 3015925378
- 3013944123
- 3009217531
- 9681384
- 3010707607
- 9614434
- 3042889296
Source Documents#
Other 510(k) Records For Product Code EOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024-01-19 |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023-02-24 |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022-12-02 |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022-10-26 |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | 2021-05-04 |
| K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021-02-18 |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020-01-24 |
| K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | 2019-06-13 |
| K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor | Cogentix Medical, Inc. | 2018-11-15 |
| K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018-08-16 |
| K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016-04-12 |
| K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014-11-26 |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-06-21 |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-06-20 |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2011-10-21 |
Legacy Summary#
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FDA Review#
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