Cytosponge Cell Collection Device
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K142695 FDA 510(k)
- FDA Product Code
- EOX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4710 FDA 510(k)
- Regulation Number
- 874.4710 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cytosponge Cell Collection Device is a diagnostic device designed for esophageal cell sampling. It is classified as an esophagoscope accessory and functions by collecting surface cells from the esophageal lining for cytological examination. The device is structured to facilitate minimally invasive procedures, enabling clinicians to obtain cellular samples for diagnostic purposes, particularly in the evaluation of esophageal conditions.
This device is supplied as a non-sterile, single-use instrument, comprising a size 00 vegetable-material-derived capsule containing a 30mm compressed spherical sponge. The capsule is attached to a silicone-coated braided polyester suture, which is secured to a retainer card via an ABS plug. It is intended for use in clinical settings by healthcare professionals, adhering to regulatory standards outlined under FDA 510(k) clearance (K142695) and classification as a Class II device under regulation number 874.4710.
Frequently asked questions
What is the Cytosponge Cell Collection Device used for in clinical practice?
The Cytosponge Cell Collection Device is designed for esophageal cell sampling, allowing clinicians to collect surface cells from the esophageal lining. This minimally invasive procedure helps in obtaining samples for cytological examination, which is particularly useful in evaluating esophageal conditions such as Barrett’s esophagus or dysplasia.
Is the Cytosponge Cell Collection Device sterile and how is it intended for use?
The Cytosponge Cell Collection Device is supplied as a non-sterile, single-use instrument. It is intended for clinical use by healthcare professionals, meaning it must be sterilized by the facility prior to use if required for a sterile procedure. The device is not pre-sterilized by the manufacturer.
How is the Cytosponge Cell Collection Device packaged and what components does it include?
The device consists of a size 00 vegetable-material-derived capsule containing a 30mm compressed spherical sponge, attached to a silicone-coated braided polyester suture. This assembly is secured to a retainer card via an ABS plug, ensuring stability during use. The entire system is designed for single-use and is non-sterile.
What regulatory pathway was followed for FDA clearance of the Cytosponge Cell Collection Device?
The Cytosponge Cell Collection Device received FDA 510(k) clearance (K142695) through a traditional review pathway, classified as a Class II device under regulation number 874.4710. The submission was reviewed by the Ear, Nose, and Throat (EN) Advisory Committee and determined to be substantially equivalent to a predicate device.
Can this device be used with any flexible or rigid esophagoscope, or are there specific compatibility requirements?
The Cytosponge Cell Collection Device is designed as an esophagoscope accessory, meaning it is intended for use with flexible or rigid esophagoscopes—no specific esophagoscope model is required. However, compatibility depends on the clinical workflow and the esophagoscope’s design, so facility-specific testing may be necessary to ensure proper integration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cytosponge Cell Collection Device by Covidien llc | FDA 510(k) Summary, Cytosponge Cell Collection Device (K181020) — FDA 510 (k) | Innolitics, Cytosponge Cell Collection Device (K152794) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142695 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K142695 24 fields · synced Sep 20, 2026