OWT
11 FDA 510(k) clearances · Product code
132 daysmedian time to decision
269 days90th percentile
11clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists during hernia repair.
- Adverse events (MAUDE)
- 2021: 58 · 2022: 104 · 2023: 77 · 2024: 65 · 2025: 84 · 2026: 49
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Phasix ST Umbilical Hernia Patch (K243241) | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 |
| Transorbâ„¢ Self-Gripping Resorbable Mesh (K233661) | Sofradim Production | 2024-02-13 |
| TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (K191749) | Novus Scientific AB | 2020-03-26 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| Phasix ST Mesh with Open Positioning System (K190185) | C.R. Bard, Inc. | 2019-06-12 |
| Phasix ST Mesh (K173143) | C.R. Bard, Inc. | 2018-04-25 |
| TIGR Matrix Surgical Mesh (K163005) | Novus Scientific AB | 2017-07-27 |
| Phasix ST Mesh (K143380) | C.R. Bard, Inc. | 2015-06-05 |
| PHASIX PLUG AND PATCH (K120728) | C.R. Bard, Inc. | 2012-10-22 |
| TEPHAFLEX COMPOSITE MESH (K101287) | Tepha, Inc. | 2010-08-30 |
| GORE BIOABSORBABLE MESH (K033671) | W. L. Gore & Associates, Inc. | 2003-12-31 |
Track OWT automatically
Every clearance here is in the API, with alerts when new ones post.