FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGISIS STAPLE LINE REINFORCEMENT
K Number: K022044
·
Decision Aug 23, 2002
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
3
Applicant Total
31
Review Days
60
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Basic Information
- Device Name
- SURGISIS STAPLE LINE REINFORCEMENT
- K Number
- K022044
- 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
- June 24, 2002
- Decision Date
- August 23, 2002
- Product Code
- OXE
- 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 |
|---|---|---|---|
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXE), ordered by most recent decision date.
Biodesign Staple Line Reinforcement
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Kerecis SecureMesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERITAS COLLAGEN MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| 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 |