FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K Number: K011500
·
Decision Dec 3, 2001
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
61
Review Days
201
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Basic Information
- Device Name
- MENTOR CONTOUR PROFILE TISSUE EXPANDER
- K Number
- K011500
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Corp.
- Date Received
- May 16, 2001
- Decision Date
- December 3, 2001
- Product Code
- LCJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
Similar 510(k) Clearances
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Mentor CPX 4 PLUS Enhance Breast Tissue Expander
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MENTOR CPX4 PLUS Enhance Breast Tissue Expander
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Motiva Flora SmoothSilk Tissue Expander
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FDA Unclassified
·Unknown
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Mentor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | Apr 11, 2013 | Substantially Equivalent |
| K053414 | MENTOR NOVASILK MESH | Dec 27, 2005 | Substantially Equivalent |
| K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | Jun 3, 2005 | Substantially Equivalent |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | Nov 9, 2004 | Substantially Equivalent |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Oct 29, 2004 | Substantially Equivalent |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | Jul 17, 2003 | Substantially Equivalent |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Oct 1, 2002 | Substantially Equivalent |
| K004005 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) | Oct 12, 2001 | Substantially Equivalent |
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | Apr 23, 2001 | Substantially Equivalent |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | Mar 29, 2001 | Substantially Equivalent |