FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Brevera Biopsy System with Corlumina Imaging Technology
K Number: K163052
·
Decision Mar 29, 2017
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
353
Applicant Total
72
Review Days
148
Basic Information
- Device Name
- Brevera Biopsy System with Corlumina Imaging Technology
- K Number
- K163052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOLOGIC, INC.
- Date Received
- November 1, 2016
- Decision Date
- March 29, 2017
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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