FDA Product Code
FDA Product Code OWT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261543 | Phasix ST Parastomal Hernia Mesh | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2026-09-28 | Traditional | PDF ↗ |
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 | Traditional | PDF ↗ |
| K233661 | Transorb Self-Gripping Resorbable Mesh | Sofradim Production | 2024-02-13 | Traditional | PDF ↗ |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020-03-26 | Traditional | PDF ↗ |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019-07-31 | Special | PDF ↗ |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019-06-12 | Traditional | PDF ↗ |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | 2018-04-25 | Traditional | PDF ↗ |
| K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017-07-27 | Traditional | PDF ↗ |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015-06-05 | Traditional | PDF ↗ |
| K120728 | PHASIX PLUG AND PATCH | C.R. Bard, Inc. | 2012-10-22 | Traditional | PDF ↗ |
| K101287 | TEPHAFLEX COMPOSITE MESH | Tepha, Inc. | 2010-08-30 | Traditional | PDF ↗ |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 | Traditional | PDF ↗ |
Product code OWT · Class II · General, Plastic Surgery. Data: openFDA.