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Fusion Cytology Brush CytoMax II Double Lumen Cytology Brushes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192908

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K192908 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 Fusion Cytology Brush CytoMax II Double Lumen Cytology Brushes is an endoscopic cytology brush designed for collecting cellular samples from the biliary system. It falls under the category of an Endoscopic Cytology Brush, a device used to obtain tissue samples for cytological examination during endoscopic procedures.

This device is supplied as a single-use, reusable component set, including a nylon brush on a stainless-steel drive wire, a double-lumen catheter with radiopaque markers, a wire guide access hub, and a pinvise handle. It is intended for use in gastroenterology and urology settings, with an FDA 510(k) clearance under the Special Review pathway and compliance with the Medical Device Directive (MDD). The brush is passed through an endoscope over a prepositioned wire guide to target the collection site.

Frequently asked questions

What special features does the Fusion Cytology Brush CytoMax II include that make it suitable for biliary system sampling during endoscopic procedures?

The Fusion Cytology Brush CytoMax II features a double-lumen catheter with radiopaque markers, allowing for precise navigation and visualization under fluoroscopy. It also includes a nylon brush on a stainless-steel drive wire for effective cellular sample collection, paired with a wire guide access hub and pinvise handle for ergonomic control. These components enable targeted sampling while being passed through an endoscope over a prepositioned wire guide, ensuring accuracy in the biliary system.

Is the Fusion Cytology Brush CytoMax II designed for single-use or reusable applications, and what components are included in the set?

The Fusion Cytology Brush CytoMax II is supplied as a single-use device, though it includes reusable components (such as the catheter and handle) as part of the set. The full set includes the nylon brush, double-lumen catheter with radiopaque markers, wire guide access hub, and pinvise handle—all designed for one-time procedural use while allowing the reusable parts to be cleaned and reused across multiple sets.

How does the regulatory pathway for this device differ from standard medical device approvals, and which advisory committees were involved?

The Fusion Cytology Brush CytoMax II received FDA 510(k) clearance under the Special Review pathway, indicating a more rigorous evaluation process than standard submissions. It was also reviewed by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its dual-use applications in these specialties. Compliance with the Medical Device Directive (MDD) further supports its regulatory standing in international markets.

What storage or handling considerations should be noted for the Fusion Cytology Brush CytoMax II before use?

Since the device is single-use, it should be stored in a sterile, sealed packaging until ready for use to maintain integrity. The reusable components (like the catheter and handle) must be cleaned and sterilized per manufacturer guidelines before reuse. Proper storage conditions—such as avoiding moisture, extreme temperatures, or contamination—are critical to preserve functionality and sterility for both single-use and reusable parts.

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: Cytomax II® Double Lumen Cytology Brush | Cook Medical, Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes, Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush, Fusion® Cytology Brush - Cook Medical, Cook Medical G22674 - BRUSH, CYTOMAX II, DBL LUMEN, CYTOLOGY, EACH

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.

Sources (2)

  • FDA 510(k) K192908 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 29, 2026