FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED BIOPSY NEEDLE
K Number: K945133
·
Decision Nov 9, 1994
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- MODIFIED BIOPSY NEEDLE
- K Number
- K945133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biopsys Medical, Inc.
- Date Received
- October 20, 1994
- Decision Date
- November 9, 1994
- 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 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 |
| K960019 | RETRACTOR ARM CLAMP | Feb 9, 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 |