Tephaflex Mesh
FDA 510(k) K111946 · Tepha, Inc.
510(k) numberK111946
Submission
- Device name
- Tephaflex Mesh
- Applicant
- Tepha, Inc.
Lexington, MA, US - Received
- July 8, 2011
- Decision date
- September 26, 2011
- 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 |
| K113723 | Tephaflex MeshOOD · Traditional | Tepha, Inc. | 02/15/2012SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | Tepha, Inc. | 02/15/2012SE |
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 |
| K113723 | Tephaflex MeshOOD · Traditional | 02/15/2012SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | 02/15/2012SE |
Questions and answers
When was Tephaflex Mesh cleared by the FDA?
Tephaflex Mesh (K111946) received a 510(k) decision of Substantially Equivalent on September 26, 2011, 80 days after the submission was received.
What is the product code of K111946?
The FDA product code is OOD – Surgical Film, a Class II (moderate risk) device regulated under 21 CFR 878.3300.