FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY NEEDLE GUIDE KIT, STERILE
K Number: K871467
·
Decision Aug 21, 1987
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
10
Review Days
129
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Basic Information
- Device Name
- BIOPSY NEEDLE GUIDE KIT, STERILE
- K Number
- K871467
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Amedic USA
- Date Received
- April 14, 1987
- Decision Date
- August 21, 1987
- 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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Other Clearances by Amedic USA
| K Number | Device Name | ||
|---|---|---|---|
| K897120 | EQUIP COVERS, STERILE | Jan 4, 1990 | Substantially Equivalent |
| K892070 | GENERAL IVT NEEDLE GUIDE KIT, STERILE | Sep 5, 1989 | Substantially Equivalent |
| K892071 | GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE | Aug 8, 1989 | Substantially Equivalent |
| K892069 | EXTENDED COVERS, STERILE | Aug 8, 1989 | Substantially Equivalent |
| K892068 | TRT (ACUSON) NEEDLE GUIDE KIT, STERILE | Aug 4, 1989 | Substantially Equivalent |
| K871565 | ULTRASOUND TRANSDUCER GEL, STERILE | Jul 15, 1987 | Substantially Equivalent |
| K871609 | ULTRASOUND TRANSDUCER SHEATHS, STERILE | Jul 15, 1987 | Substantially Equivalent |
| K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE | Jul 10, 1987 | Substantially Equivalent |
| K864219 | TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE | Mar 27, 1987 | Substantially Equivalent |