FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HORIZONTAL NEEDLE GUIDE ATTACHMENT
K Number: K925875
·
Decision Apr 6, 1993
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
27
Applicant Total
7
Review Days
138
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Basic Information
- Device Name
- HORIZONTAL NEEDLE GUIDE ATTACHMENT
- K Number
- K925875
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bip USA, Inc.
- Date Received
- November 19, 1992
- Decision Date
- April 6, 1993
- Product Code
- GDF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDF | Guide, Needle, Surgical | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Bip USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K024089 | VACUFLASH BIOPSY SYSTEM | Mar 11, 2003 | Substantially Equivalent |
| K934371 | BIP MULTI MODIFICATION | Apr 28, 1994 | Substantially Equivalent |
| K934370 | BIP BIOPSY NEEDLE MODIFICATION | Mar 7, 1994 | Substantially Equivalent |
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL | Feb 17, 1994 | Substantially Equivalent |
| K925870 | SPACER | May 19, 1993 | Substantially Equivalent |
| K925874 | BREAST STABILIZER | Mar 16, 1993 | Substantially Equivalent |