FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
K Number: K042851
·
Decision Nov 9, 2004
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
61
Review Days
25
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Basic Information
- Device Name
- MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
- K Number
- K042851
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Corp.
- Date Received
- October 15, 2004
- Decision Date
- November 9, 2004
- Product Code
- OTN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| 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 |