FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETHRA-BRUSH
K Number: K942144
·
Decision Jun 27, 1994
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
3
Review Days
55
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- URETHRA-BRUSH
- K Number
- K942144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rovers Diagnostic Devices
- Date Received
- May 3, 1994
- Decision Date
- June 27, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FDX), ordered by most recent decision date.
Single Use Cytology Brush V (BC-V600P-3010)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Cytology Brush
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Deflectable Brush Biopsy Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Brush Biopsy Set ; Deflectable Brush Biopsy Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology