FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY SITE TISSUE MARKER DEVICE
K Number: K023450
·
Decision Dec 19, 2002
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
18
Review Days
65
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Basic Information
- Device Name
- BIOPSY SITE TISSUE MARKER DEVICE
- K Number
- K023450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promex, Inc.
- Date Received
- October 15, 2002
- Decision Date
- December 19, 2002
- Product Code
- NEU
- 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 |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Promex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022634 | CO-AXIAL INTRODUCER NEEDLE | Nov 6, 2002 | Substantially Equivalent |
| K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE | Jul 24, 2001 | Substantially Equivalent |
| K011270 | AUTOMATED CORE BIOPSY DEVICE | Jun 22, 2001 | Substantially Equivalent |
| K001132 | BONE BIOPSY NEEDLE | May 1, 2000 | Substantially Equivalent |
| K994272 | AUTOMATED CORE BIOPSY DEVICE | Jan 7, 2000 | Substantially Equivalent |
| K993435 | MANUAL BONE MARROW BIOPSY DEVICE | Dec 6, 1999 | Substantially Equivalent |
| K973184 | PROSTATE SEEDING NEEDLE | Nov 21, 1997 | Substantially Equivalent |
| K972865 | PROMEX ENT TISSUE REMOVAL SYSTEM | Sep 29, 1997 | Substantially Equivalent |
| K961078 | AUTOMATED VITRECTOMY DEVICE | Jun 14, 1996 | Substantially Equivalent |
| K960023 | KIRSHNER WIRES (K-WIRE) & STEINMANN PINS | Mar 18, 1996 | Substantially Equivalent |