Product code OWT
- Device name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For reinforcement of soft tissue where weakness exists during hernia repair.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 |
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024-02-13 |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020-03-26 |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019-07-31 |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019-06-12 |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | 2018-04-25 |
| K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017-07-27 |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015-06-05 |
| K120728 | PHASIX PLUG AND PATCH | C.R. Bard, Inc. | 2012-10-22 |
| K101287 | TEPHAFLEX COMPOSITE MESH | Tepha, Inc. | 2010-08-30 |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10653405988946 | BioBrace | Conmed Corporation | 2024-02-12 |
| 00801741161247 | Phasix | Davol Inc. | 2019-08-16 |
| 00801741161261 | Phasix | Davol Inc. | 2019-07-12 |
| 00801741161254 | Phasix | Davol Inc. | 2019-07-12 |
| 00801741161230 | Phasix | Davol Inc. | 2019-07-12 |
| 00733132644582 | GORE ENFORM Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644599 | GORE ENFORM Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644612 | GORE ENFORM Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644636 | GORE ENFORM Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644667 | GORE ENFORM Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644674 | GORE ENFORM Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644681 | GORE ENFORM Intraperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644704 | GORE ENFORM Intraperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132644728 | GORE ENFORM Intraperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2018-09-28 |
| 00733132605415 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132606153 | GORE BIO-A Hernia Plug | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132605453 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132605439 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132605422 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00801741095276 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095283 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095290 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095313 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095337 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095351 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095368 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095375 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741095382 | Phasix | Davol Inc. | 2015-08-05 |
| 00801741010620 | Phasix | Davol Inc. | 2015-05-18 |
| 00801741010637 | Phasix | Davol Inc. | 2015-05-17 |