FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
K Number: K970565
·
Decision Mar 28, 1997
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
15
Review Days
43
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Basic Information
- Device Name
- MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
- K Number
- K970565
- 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
- February 13, 1997
- Decision Date
- March 28, 1997
- 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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Other Clearances by Biopsys Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970817 | MICROMARK CLIP | Sep 11, 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 |
| K945573 | BIOPSY DEVICE ACCESSORY | Dec 9, 1994 | Substantially Equivalent |