FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEPHAFLEX SURGICAL FILM
K Number: K072520
·
Decision Nov 29, 2007
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
18
Review Days
83
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Basic Information
- Device Name
- TEPHAFLEX SURGICAL FILM
- K Number
- K072520
- 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
- September 7, 2007
- Decision Date
- November 29, 2007
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | Apr 9, 2024 | Substantially Equivalent |
| K202425 | SurgiLattice scaffold | Aug 19, 2021 | Substantially Equivalent |
| K211307 | GalaSTITCH Absorbable Monofilament Suture | May 27, 2021 | Substantially Equivalent |
| K162922 | GalaFORM 3D | Feb 23, 2017 | Substantially Equivalent |
| K161092 | GalaSHAPE 3D | Aug 23, 2016 | Substantially Equivalent |
| K140533 | GALAFLEX MESH | May 21, 2014 | 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 |