FDA product code OXC: Mesh, Surgical, Absorbable, Staple Line Reinforcement
OXC is the FDA product code for mesh, surgical, absorbable, staple line reinforcement. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 9 510(k) submissions under OXC, 4 in the last five years, from 4 different applicants. The average 510(k) review took 114 days (median 119); 119 days on average over the last three years.
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OXC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 29 |
| 2019 | 1 | 187 |
| 2022 | 2 | 112 |
| 2023 | 1 | 127 |
| 2026 | 1 | 119 |
Compare with all 510(k) review times · Search every OXC clearance
Top OXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ethicon Endo-Surgery, LLC | 3 | 2026-01-09 |
| W. L. Gore & Associates, Inc. | 3 | 2018-08-17 |
| Gunze Limited | 2 | 2022-08-26 |
| Standard Bariatrics, Inc. | 1 | 2023-10-06 |
Most recent OXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252906 | Ethicon Endo-Surgery, LLC | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | 2026-01-09 | 119 |
| K231603 | Standard Bariatrics, Inc. | Standard Staple-Line Reinforcement (SSLR23) | 2023-10-06 | 127 |
| K221343 | Ethicon Endo-Surgery, LLC | ECHELON ENDOPATH Staple Line Reinforcement | 2022-09-16 | 130 |
| K221487 | Gunze Limited | NEOVEIL Staple Line Reinforcement | 2022-08-26 | 95 |
| K190937 | Ethicon Endo-Surgery, LLC | Echelon Endopath Staple Line Reinforcement | 2019-10-14 | 187 |
Recalls for OXC devices
openFDA lists no recalls for product code OXC.
Frequently asked questions
What is FDA product code OXC?
OXC is the FDA product code for mesh, surgical, absorbable, staple line reinforcement. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is OXC?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXC?
Across 9 cleared submissions the average was 114 days from receipt to decision (median 119).
Which companies have the most OXC clearances?
Ethicon Endo-Surgery, LLC (3); W. L. Gore & Associates, Inc. (3); Gunze Limited (2); Standard Bariatrics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXC
- Run a recall and safety report across every OXC manufacturer
- Watch product code OXC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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