Cytosponge Cell Collection Device
FDA 510(k) K181020 · Covidien, LLC
510(k) numberK181020
Submission
- Device name
- Cytosponge Cell Collection Device
- Applicant
- Covidien, LLC
Mansfield, MA, US - Received
- April 17, 2018
- Decision date
- August 16, 2018
- 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 |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)EOX · Traditional | Capnostics, LLC | 05/04/2021SE |
| 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 |
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| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | 12/03/2024SE |
Questions and answers
When was Cytosponge Cell Collection Device cleared by the FDA?
Cytosponge Cell Collection Device (K181020) received a 510(k) decision of Substantially Equivalent on August 16, 2018, 121 days after the submission was received.
What is the product code of K181020?
The FDA product code is EOX – Esophagoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4710.