EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
FDA 510(k) K203450 · Capnostics, LLC
510(k) numberK203450
Submission
- Device name
- EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
- Applicant
- Capnostics, LLC
Concord, NC, US - Received
- November 23, 2020
- Decision date
- May 4, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102)EOX · Traditional | Cyted Limited | 01/19/2024SE |
| K230339 | EsoCheck Cell Collection DeviceEOX · Special | Lucid Diagnostics, Inc. | 02/24/2023SESK |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10EOX · Traditional | Pentax of America, Inc. | 12/02/2022SE |
| K222366 | EsoCheck Cell Collection DeviceEOX · Traditional | Lucid Diagnostics, Inc. | 10/26/2022SESK |
| K210137 | EsoCheck Cell Collection DeviceEOX · Special | Lucid Diagnostics, Inc. | 02/18/2021SESK |
| K192523 | CMOS Video Esophagoscope SSUEOX · Traditional | Karl Storz SE & CO. KG | 01/24/2020SE |
| K183262 | EsoCheck CCD Cell Collection DeviceEOX · Traditional | Lucid Diagnostics, Inc. | 06/21/2019SESK |
| K182159 | Strome-Blitzer Cytology BalloonEOX · Traditional | Adn International, LLC | 06/13/2019SE |
| K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video ProcessorEOX · Traditional | Cogentix Medical, Inc. | 11/15/2018SE |
| K181020 | Cytosponge Cell Collection DeviceEOX · Traditional | Covidien, LLC | 08/16/2018SE |
Questions and answers
When was EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) cleared by the FDA?
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) (K203450) received a 510(k) decision of Substantially Equivalent on May 4, 2021, 162 days after the submission was received.
What is the product code of K203450?
The FDA product code is EOX – Esophagoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4710.