Panels › General, Plastic Surgery › Product code OWT · Class 2
Mesh, Surgical, Absorbable, Abdominal Hernia
Regulation 878.3300
2510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OWT
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 4 | 0 |
| Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2 | 0 |
| Novus Scientific AB | 2 | 0 |
| Sofradim Production | 2 | 0 |
| W. L. Gore & Associates, Inc. | 2 | 0 |
| Tepha, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K262443 | Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) Sofradim Production, FR | OWT |
| Sep 28, 2026 | K261543 | Phasix ST Parastomal Hernia Mesh Davol, Inc., A Subsidiary of C.R. Bard, Inc. | OWT |
| Feb 19, 2025 | K243241 | Phasix ST Umbilical Hernia Patch Davol, Inc., A Subsidiary of C.R. Bard, Inc. | OWT |
| Feb 13, 2024 | K233661 | Transorb Self-Gripping Resorbable Mesh Sofradim Production, FR | OWT |
| Mar 26, 2020 | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh Novus Scientific AB, SE | OWT |
| Jul 31, 2019 | K191773 | GORE BIO-A Tissue Reinforcement W. L. Gore & Associates, Inc. | OWT |
| Jun 12, 2019 | K190185 | Phasix ST Mesh with Open Positioning System C.R. Bard, Inc. | OWT |
| Apr 25, 2018 | K173143 | Phasix ST Mesh C.R. Bard, Inc. | OWT |
| Jul 27, 2017 | K163005 | TIGR Matrix Surgical Mesh Novus Scientific AB, SE | OWT |
| Jun 5, 2015 | K143380 | Phasix ST Mesh C.R. Bard, Inc. | OWT |
| Oct 22, 2012 | K120728 | PHASIX PLUG AND PATCH C.R. Bard, Inc. | OWT |
| Aug 30, 2010 | K101287 | TEPHAFLEX COMPOSITE MESH Tepha, Inc. | OWT |
| Dec 31, 2003 | K033671 | GORE BIOABSORBABLE MESH W. L. Gore & Associates, Inc. | OWT |
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