EsoCheck Cell Collection Device
FDA 510(k) clearance K222366 · decided 2022-10-26
Clearance details
- K-number
- K222366
- Device name
- EsoCheck Cell Collection Device
- Applicant
- Lucid Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2022-08-04
- Decision date
- 2022-10-26
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- EOX
- Device class
- 2
- Regulation number
- 874.4710
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EndoSign® Cell collection device (ES-CYT-102) (K233142) | Cyted Limited | 2024-01-19 |
| EsoCheck Cell Collection Device (K230339) | Lucid Diagnostics, Inc. | 2023-02-24 |
| PENTAX Medical Video Esophagoscope EE17-J10 (K223072) | Pentax of America, Inc. | 2022-12-02 |
| EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) (K203450) | Capnostics, LLC | 2021-05-04 |
| EsoCheck Cell Collection Device (K210137) | Lucid Diagnostics, Inc. | 2021-02-18 |
| CMOS Video Esophagoscope SSU (K192523) | Karl Storz SE & CO. KG | 2020-01-24 |
| EsoCheck CCD Cell Collection Device (K183262) | Lucid Diagnostics, Inc. | 2019-06-21 |
| Strome-Blitzer Cytology Balloon (K182159) | Adn International, LLC | 2019-06-13 |
| PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (K181292) | Cogentix Medical, Inc. | 2018-11-15 |
| Cytosponge Cell Collection Device (K181020) | Covidien, LLC | 2018-08-16 |
| Cytosponge Cell Collection Device (K152794) | Covidien, LLC | 2016-04-12 |
| Cytosponge Cell Collection Device (K142695) | Covidien, LLC | 2014-11-26 |
Recalls involving this device
No recalls on record reference this clearance.