FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K Number: K131015
·
Decision Oct 8, 2013
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
31
Review Days
180
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Basic Information
- Device Name
- BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
- K Number
- K131015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Biotech, Inc.
- Date Received
- April 11, 2013
- Decision Date
- October 8, 2013
- Product Code
- GXQ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXQ | Dura Substitute | FDA class 2 | Neurology |
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Other Clearances by Cook Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133306 | SIS HERNIA GRAFT | Jul 23, 2014 | Substantially Equivalent |
| K133011 | DIAPHRAGMATIC HERNIA GRAFT | Jun 20, 2014 | 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 |