Tephaflex Composite Mesh
FDA 510(k) K101287 · Tepha, Inc.
510(k) numberK101287
Submission
- Device name
- Tephaflex Composite Mesh
- Applicant
- Tepha, Inc.
Lexington, MA, US - Received
- May 7, 2010
- Decision date
- August 30, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWT – Mesh, Surgical, Absorbable, Abdominal Hernia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists during hernia repair.
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| K233661 | Transorb Self-Gripping Resorbable MeshOWT · Traditional | Sofradim Production | 02/13/2024SE |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical MeshOWT · Traditional | Novus Scientific AB | 03/26/2020SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | W. L. Gore & Associates, Inc. | 07/31/2019SE |
| K190185 | Phasix ST Mesh with Open Positioning SystemOWT · Traditional | C.R. Bard, Inc. | 06/12/2019SE |
| K173143 | Phasix ST MeshOWT · Traditional | C.R. Bard, Inc. | 04/25/2018SE |
| K163005 | TIGR Matrix Surgical MeshOWT · Traditional | Novus Scientific AB | 07/27/2017SE |
| K143380 | Phasix ST MeshOWT · Traditional | C.R. Bard, Inc. | 06/05/2015SE |
| K120728 | Phasix Plug and PatchOWT · Traditional | C.R. Bard, Inc. | 10/22/2012SE |
| K033671 | Gore Bioabsorbable MeshOWT · Traditional | W. L. Gore & Associates, Inc. | 12/31/2003SE |
More from W. L. Gore & Associates, Inc.
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|---|---|---|
| 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 Composite Mesh cleared by the FDA?
Tephaflex Composite Mesh (K101287) received a 510(k) decision of Substantially Equivalent on August 30, 2010, 115 days after the submission was received.
What is the product code of K101287?
The FDA product code is OWT – Mesh, Surgical, Absorbable, Abdominal Hernia, a Class II (moderate risk) device regulated under 21 CFR 878.3300.