OXC
9 FDA 510(k) clearances · Product code
119 daysmedian time to decision
219 days90th percentile
9clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Absorbable, Staple Line Reinforcement
- 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 staple line reinforcement procedures.
- Adverse events (MAUDE)
- 2021: 33 · 2022: 164 · 2023: 26 · 2024: 38 · 2025: 45 · 2026: 34
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 |
|---|---|---|
| ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (K252906) | Ethicon Endo-Surgery, LLC | 2026-01-09 |
| Standard Staple-Line Reinforcement (SSLR23) (K231603) | Standard Bariatrics, Inc. | 2023-10-06 |
| ECHELON ENDOPATH Staple Line Reinforcement (K221343) | Ethicon Endo-Surgery, LLC | 2022-09-16 |
| NEOVEIL Staple Line Reinforcement (K221487) | Gunze Limited | 2022-08-26 |
| Echelon Endopath Staple Line Reinforcement (K190937) | Ethicon Endo-Surgery, LLC | 2019-10-14 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE SEAMGUARD Reinforcement (K150551) | W. L. Gore & Associates, Inc. | 2015-03-30 |
| NEOVEIL (K130997) | Gunze Limited | 2013-11-15 |
| GORE SEAMGUARD REINFORCEMENT (K131658) | W. L. Gore & Associates, Inc. | 2013-09-06 |
Track OXC automatically
Every clearance here is in the API, with alerts when new ones post.