FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIS HERNIA GRAFT
K Number: K133306
·
Decision Jul 23, 2014
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
31
Review Days
268
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Basic Information
- Device Name
- SIS HERNIA GRAFT
- K Number
- K133306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Biotech, Inc.
- Date Received
- October 28, 2013
- Decision Date
- July 23, 2014
- Product Code
- FTM
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cook Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133011 | DIAPHRAGMATIC HERNIA GRAFT | Jun 20, 2014 | Substantially Equivalent |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Oct 8, 2013 | Substantially Equivalent |
| K111695 | HYBRID GRAFT | Apr 2, 2012 | Substantially Equivalent |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | Jun 20, 2011 | Substantially Equivalent |
| K090688 | COOK UROLOGICAL GRAFT | Jul 10, 2009 | Substantially Equivalent |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | Feb 27, 2009 | Substantially Equivalent |
| K082058 | DYNAMATRIX | Oct 2, 2008 | Substantially Equivalent |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | Mar 21, 2008 | Substantially Equivalent |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | Oct 17, 2007 | Substantially Equivalent |
| K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | Apr 5, 2007 | Substantially Equivalent |