FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K Number: K004005
·
Decision Oct 12, 2001
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
61
Review Days
290
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Basic Information
- Device Name
- MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
- K Number
- K004005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Corp.
- Date Received
- December 26, 2000
- Decision Date
- October 12, 2001
- Product Code
- QPB
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | Dec 3, 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 |