FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALAFLEX MESH
K Number: K140533
·
Decision May 21, 2014
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
14
Review Days
78
Basic Information
- Device Name
- GALAFLEX MESH
- K Number
- K140533
- 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
- TEPHA, INC.
- Date Received
- March 4, 2014
- Decision Date
- May 21, 2014
- Product Code
- OOD
- 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 |
|---|---|---|---|
| OOD | Surgical Film | FDA class 2 | General, Plastic Surgery |
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Other Clearances by TEPHA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162922 | GalaFORM 3D | Feb 23, 2017 | Substantially Equivalent |
| K132348 | TEPHAFLEX BRAIDED SUTURE | Sep 5, 2013 | Substantially Equivalent |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | May 7, 2013 | Substantially Equivalent |
| K113721 | TEPHAFLEX LIGHT MESH | Feb 15, 2012 | Substantially Equivalent |
| K113723 | TEPHAFLEX MESH | Feb 15, 2012 | Substantially Equivalent |
| K111946 | TEPHAFLEX MESH | Sep 26, 2011 | Substantially Equivalent |
| K101287 | TEPHAFLEX COMPOSITE MESH | Aug 30, 2010 | Substantially Equivalent |
| K091633 | TEPHAFLEX SURGICAL FILM | Aug 7, 2009 | Substantially Equivalent |
| K082178 | TEPHAFLEX ABSORBABLE SUTURE | Oct 30, 2008 | Substantially Equivalent |
| K081099 | TEPHAFLEX ABSORBABLE SUTURE | Jul 15, 2008 | Substantially Equivalent |