EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
FDA 510(k) clearance K203450 · decided 2021-05-04
Clearance details
- K-number
- K203450
- Device name
- EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
- Applicant
- Capnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-11-23
- Decision date
- 2021-05-04
- Days to decision
- 162 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
- Concord, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Capnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| EsoCheck Cell Collection Device (K222366) | Lucid Diagnostics, Inc. | 2022-10-26 |
| 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
| Record | Firm | Date |
|---|---|---|
| Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog recall (Z-1899-2024) | Lucid Diagnostics, Inc. | 2024-05-24 |
| Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog recall (Z-1900-2024) | Lucid Diagnostics, Inc. | 2024-05-24 |