FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K Number: K171573
·
Decision Dec 29, 2017
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
125
Review Days
213
Basic Information
- Device Name
- Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K Number
- K171573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilson-Cook Medical, Inc.
- Date Received
- May 30, 2017
- Decision Date
- December 29, 2017
- Product Code
- FDX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDX | Endoscopic Cytology Brush | FDA class 2 | Gastroenterology, Urology |
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