FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Deflectable Brush Biopsy Set
K Number: K191485
·
Decision Jun 26, 2019
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
175
Review Days
22
Basic Information
- Device Name
- Deflectable Brush Biopsy Set
- K Number
- K191485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- June 4, 2019
- Decision Date
- June 26, 2019
- 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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