OXC · Mesh, Surgical, Absorbable, Staple Line Reinforcement
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OXC |
|---|---|
| Device Name | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | Jan 9, 2026 | SESE |
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. | Oct 6, 2023 | SESE |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | Sep 16, 2022 | SESE |
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | Aug 26, 2022 | SESE |
| K190937 | Echelon Endopath Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | Oct 14, 2019 | SESE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | Aug 17, 2018 | SESE |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | Mar 30, 2015 | SESE |
| K130997 | NEOVEIL | Gunze Limited | Nov 15, 2013 | SESE |
| K131658 | GORE SEAMGUARD REINFORCEMENT | W. L. Gore & Associates, Inc. | Sep 6, 2013 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 3 clearances
- Ethicon Endo-Surgery, LLC — 3 clearances
- Gunze Limited — 2 clearances
- Standard Bariatrics, Inc. — 1 clearance
