Fusion Cytology Brush CytoMax II Double Lumen Cytology Brush
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181317 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 is an endoscopic cytology brush designed for the collection of cellular samples. Classified as an Endoscopic Cytology Brush, it is intended for use in diagnostic procedures to obtain tissue samples from internal body cavities or organs, aiding in cytological examination for pathological analysis.
This device is supplied as a single-use, non-sterile instrument, intended for use in both gastroenterology and urology settings. It features a double lumen design for enhanced sample collection and is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD). The brush is available in a specific model reference and adheres to regulatory standards for endoscopic diagnostic tools, ensuring compliance with medical device classification 2.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181317 | Class II | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
Sources (2)
- FDA 510(k) K181317 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026