FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RETRACTOR ARM CLAMP
K Number: K960019
·
Decision Feb 9, 1996
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
15
Review Days
38
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Basic Information
- Device Name
- RETRACTOR ARM CLAMP
- K Number
- K960019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biopsys Medical, Inc.
- Date Received
- January 2, 1996
- Decision Date
- February 9, 1996
- Product Code
- FWZ
- 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Biopsys Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970817 | MICROMARK CLIP | Sep 11, 1997 | Substantially Equivalent |
| K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | Mar 28, 1997 | Substantially Equivalent |
| K963015 | SURGICAL STAPLE MARKER DEVICE (MODIFY) | Oct 7, 1996 | Substantially Equivalent |
| K953962 | FORCEPS | Sep 8, 1995 | Substantially Equivalent |
| K953880 | BIOPSY NEEDLE | Sep 8, 1995 | Substantially Equivalent |
| K951326 | BIOPSY DEVICE ACCESSORY | May 15, 1995 | Substantially Equivalent |
| K951229 | MODIFIED BIOPSY NEEDLE | Apr 6, 1995 | Substantially Equivalent |
| K950006 | SURGICAL STAPLE MARKER | Mar 15, 1995 | Substantially Equivalent |
| K943863 | NEEDLE GUIDE | Dec 29, 1994 | Substantially Equivalent |
| K945573 | BIOPSY DEVICE ACCESSORY | Dec 9, 1994 | Substantially Equivalent |