Tephaflex Mesh
FDA 510(k) K113723 · Tepha, Inc.
510(k) numberK113723
Submission
- Device name
- Tephaflex Mesh
- Applicant
- Tepha, Inc.
Lexington, MA, US - Received
- December 19, 2011
- Decision date
- February 15, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOD – Surgical Film
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
- Life-sustaining
- Yes
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical…
Other 510(k)s with product code OOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233999 | GalaFLEX LITE ScaffoldOOD · Traditional | Tepha, Inc. | 04/09/2024SE |
| K202425 | SurgiLattice scaffoldOOD · Traditional | Tepha, Inc. | 08/19/2021SE |
| K162922 | GalaFORM 3DOOD · Traditional | Tepha, Inc. | 02/23/2017SE |
| K161424 | Phasix MeshOOD · Traditional | C.R. Bard, Inc. | 09/29/2016SE |
| K161092 | GalaSHAPE 3DOOD · Traditional | Tepha, Inc. | 08/23/2016SE |
| K142818 | Phasix MeshOOD · Traditional | C. R. Bard | 03/31/2015SE |
| K140533 | Galaflex MeshOOD · Traditional | Tepha, Inc. | 05/21/2014SE |
| K130326 | Tephaflex Meltblown ConstructOOD · Traditional | Tepha, Inc. | 05/07/2013SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | Tepha, Inc. | 02/15/2012SE |
| K111946 | Tephaflex MeshOOD · Traditional | Tepha, Inc. | 09/26/2011SE |
More from Tepha, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233999 | GalaFLEX LITE ScaffoldOOD · Traditional | 04/09/2024SE |
| K202425 | SurgiLattice scaffoldOOD · Traditional | 08/19/2021SE |
| K211307 | GalaSTITCH Absorbable Monofilament SutureNWJ · Special | 05/27/2021SE |
| K162922 | GalaFORM 3DOOD · Traditional | 02/23/2017SE |
| K161092 | GalaSHAPE 3DOOD · Traditional | 08/23/2016SE |
| K140533 | Galaflex MeshOOD · Traditional | 05/21/2014SE |
| K132348 | Tephaflex Braided SutureNWJ · Traditional | 09/05/2013SE |
| K130326 | Tephaflex Meltblown ConstructOOD · Traditional | 05/07/2013SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | 02/15/2012SE |
| K111946 | Tephaflex MeshOOD · Traditional | 09/26/2011SE |
Questions and answers
When was Tephaflex Mesh cleared by the FDA?
Tephaflex Mesh (K113723) received a 510(k) decision of Substantially Equivalent on February 15, 2012, 58 days after the submission was received.
What is the product code of K113723?
The FDA product code is OOD – Surgical Film, a Class II (moderate risk) device regulated under 21 CFR 878.3300.