Transorb Self-Gripping Resorbable Mesh
FDA 510(k) K233661 · Sofradim Production
510(k) numberK233661
Submission
- Device name
- Transorb Self-Gripping Resorbable Mesh
- Applicant
- Sofradim Production
Trévoux, FR - Received
- November 15, 2023
- Decision date
- February 13, 2024
- 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.
Other 510(k)s with product code OWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia PatchOWT · Traditional | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 02/19/2025SE |
| 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 |
| K101287 | Tephaflex Composite MeshOWT · Traditional | Tepha, Inc. | 08/30/2010SE |
| K033671 | Gore Bioabsorbable MeshOWT · Traditional | W. L. Gore & Associates, Inc. | 12/31/2003SE |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL · Traditional | 05/21/2026SE |
| K250869 | Parietene Macroporous Mesh (PPM5050 )FTL · Special | 04/23/2025SE |
| K243315 | ProGrip Self-Gripping Polypropylene MeshFTL · Traditional | 01/17/2025SE |
| K232373 | Progrip Self-Gripping Polypropylene MeshFTL · Traditional | 01/18/2024SE |
| K223218 | Parietene Macroporous MeshFTL · Special | 12/02/2022SE |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…FTL · Special | 06/22/2022SE |
| K192443 | Dextile Anatomical MeshFTL · Traditional | 12/06/2019SE |
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…FTL · Traditional | 03/09/2018SE |
| K172395 | Duatene bilayer meshFTL · Traditional | 02/01/2018SE |
| K163212 | Parietene DS Composite MeshFTL · Traditional | 06/29/2017SE |
Questions and answers
When was Transorb Self-Gripping Resorbable Mesh cleared by the FDA?
Transorb Self-Gripping Resorbable Mesh (K233661) received a 510(k) decision of Substantially Equivalent on February 13, 2024, 90 days after the submission was received.
What is the product code of K233661?
The FDA product code is OWT – Mesh, Surgical, Absorbable, Abdominal Hernia, a Class II (moderate risk) device regulated under 21 CFR 878.3300.