Panels › General, Plastic Surgery › Product code OXC · Class 2
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Regulation 878.3300
1510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OXC
| Company | 510(k)s | Recalls |
|---|---|---|
| Ethicon Endo-Surgery, LLC | 3 | 0 |
| W. L. Gore & Associates, Inc. | 3 | 0 |
| Gunze Limited | 2 | 0 |
| Standard Bariatrics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2026 | K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) Ethicon Endo-Surgery, LLC | OXC |
| Oct 6, 2023 | K231603 | Standard Staple-Line Reinforcement (SSLR23) Standard Bariatrics, Inc. | OXC |
| Sep 16, 2022 | K221343 | ECHELON ENDOPATH Staple Line Reinforcement Ethicon Endo-Surgery, LLC | OXC |
| Aug 26, 2022 | K221487 | NEOVEIL Staple Line Reinforcement Gunze Limited, JP | OXC |
| Oct 14, 2019 | K190937 | Echelon Endopath Staple Line Reinforcement Ethicon Endo-Surgery, LLC | OXC |
| Aug 17, 2018 | K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc. | OXC |
| Mar 30, 2015 | K150551 | GORE SEAMGUARD Reinforcement W. L. Gore & Associates, Inc. | OXC |
| Nov 15, 2013 | K130997 | NEOVEIL Gunze Limited, JP | OXC |
| Sep 6, 2013 | K131658 | GORE SEAMGUARD REINFORCEMENT W. L. Gore & Associates, Inc. | OXC |
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