FDA Product Code
FDA Product Code OXC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | 2026-01-09 | Traditional | PDF ↗ |
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | 2022-09-16 | Traditional | PDF ↗ |
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | 2022-08-26 | Special | PDF ↗ |
| K190937 | Echelon Endopath Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | 2019-10-14 | Traditional | PDF ↗ |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | 2018-08-17 | Special | PDF ↗ |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | 2015-03-30 | Special | PDF ↗ |
| K130997 | NEOVEIL | Gunze Limited | 2013-11-15 | Traditional | PDF ↗ |
| K131658 | GORE SEAMGUARD REINFORCEMENT | W. L. Gore & Associates, Inc. | 2013-09-06 | Traditional | PDF ↗ |
Product code OXC · Class II · General, Plastic Surgery. Data: openFDA.