FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY SITE MARKER
K Number: K011402
·
Decision Jul 16, 2001
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
30
Review Days
70
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Basic Information
- Device Name
- BIOPSY SITE MARKER
- K Number
- K011402
- 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
- Senorx, Inc.
- Date Received
- May 7, 2001
- Decision Date
- July 16, 2001
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Senorx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | Mar 31, 2021 | Substantially Equivalent |
| K161805 | EnCor MRI Introducer Set, EnCor Probe Introducer | Jul 19, 2016 | Substantially Equivalent |
| K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | Jun 27, 2013 | Substantially Equivalent |
| K093512 | ENCOR BREAST BIOPSY SYSTEM | Nov 20, 2009 | Substantially Equivalent |
| K092323 | CONTURA CAVITY MAINTENANCE CATHETER | Aug 19, 2009 | Substantially Equivalent |
| K082264 | CONTURA LUMEN MARKER | Sep 12, 2008 | Unknown |
| K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | Aug 1, 2008 | Substantially Equivalent |
| K081170 | PROSTATE TISSUE MARKER | May 28, 2008 | Substantially Equivalent |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | May 2, 2008 | Unknown |