FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K Number: K012224
·
Decision Aug 22, 2001
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
12
Review Days
67
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Basic Information
- Device Name
- SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
- K Number
- K012224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ranfac, Corp.
- Date Received
- June 16, 2001
- Decision Date
- August 22, 2001
- 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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| K961922 | RDP-2 | Aug 9, 1996 | Substantially Equivalent |
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