FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASTROINTESTINAL CYTOLOGY BRUSH
K Number: K860997
·
Decision May 2, 1986
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
37
Review Days
45
Basic Information
- Device Name
- GASTROINTESTINAL CYTOLOGY BRUSH
- K Number
- K860997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endovations
- Date Received
- March 18, 1986
- Decision Date
- May 2, 1986
- 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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