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Wilson-Cook Cytology Brushes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K896318

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K896318 FDA 510(k)
FDA Product Code
FDX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wilson-Cook Cytology Brushes are endoscopic cytology brushes designed for the collection of cellular samples. These devices fall under the classification of an Endoscopic Cytology Brush, intended for use in diagnostic procedures to obtain tissue samples from internal body cavities or ducts, such as the biliary system or urinary tract.

These brushes are supplied as single-use, non-sterile devices and are regulated under FDA 510(k) clearance (K896318). They are classified as Class II medical devices under regulation number 876.1500 and are intended for use in gastroenterology and urology settings. The brushes are available in various sizes and configurations, as indicated by the associated product codes (FDX). No third-party review is required for these devices.

Frequently asked questions

What are the Wilson-Cook Cytology Brushes used for?

The Wilson-Cook Cytology Brushes are designed specifically for collecting cellular samples during endoscopic procedures. They are intended for use in diagnostic settings to obtain tissue samples from internal body cavities or ducts, such as the biliary system or urinary tract. This makes them essential tools in gastroenterology and urology for identifying abnormalities like tumors or infections.

Are these brushes single-use or reusable?

These brushes are supplied as single-use devices. This design ensures patient safety by preventing cross-contamination between procedures, as each brush is intended for one-time use only. Single-use devices also reduce the risk of infection and simplify sterilization processes.

What sizes or configurations are available for the Wilson-Cook Cytology Brushes?

The Wilson-Cook Cytology Brushes come in various sizes and configurations, each identified by specific product codes (e.g., FDX). These variations allow clinicians to select the appropriate brush for different anatomical sites or procedural requirements, ensuring optimal sample collection efficiency.

Are these brushes sterile when supplied?

No, the Wilson-Cook Cytology Brushes are supplied in a non-sterile state. They are intended to be used immediately after opening and do not require sterilization before use. This is a standard practice for single-use diagnostic devices to maintain usability and reduce unnecessary processing steps.

How should these brushes be stored before use?

Before use, these brushes should be stored in a clean, dry environment as per manufacturer guidelines. Since they are single-use and non-sterile, it is important to avoid exposure to moisture or contamination. Always check the packaging for any specific storage instructions provided by Wilson-Cook Medical, Inc.

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: Cytology Brush - Cook Medical, WILSON-COOK CYTOLOGY BRUSHES (K896318) — FDA 510(k) | Innolitics, K896318 FDA 510 (k) - WILSON-COOK CYTOLOGY BRUSHES, Fusion® Cytology Brush - Cook Medical, Cytology Brush | Cook Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.

Sources (1)

  • FDA 510(k) K896318 24 fields · synced Oct 1, 2026