FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORE MEDICAL BIOPSY NEEDLE
K Number: K914732
·
Decision Jan 7, 1992
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- CORE MEDICAL BIOPSY NEEDLE
- K Number
- K914732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core Medical, Inc.
- Date Received
- October 21, 1991
- Decision Date
- January 7, 1992
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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