FDA product code OXD: Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
OXD is the FDA product code for mesh, surgical, non-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 3 510(k) submissions under OXD. The average 510(k) review took 49 days (median 54).
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-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 |
Compare with all 510(k) review times · Search every OXD clearance
Top OXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 3 | 2001-05-21 |
Most recent OXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010936 | W. L. Gore & Associates, Inc. | MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | 2001-05-21 | 54 |
| K001789 | W. L. Gore & Associates, Inc. | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | 2000-07-06 | 23 |
| K955364 | W. L. Gore & Associates, Inc. | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | 1996-02-01 | 71 |
Recalls for OXD devices
openFDA lists no recalls for product code OXD.
Frequently asked questions
What is FDA product code OXD?
OXD is the FDA product code for mesh, surgical, non-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 OXD?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXD?
Across 3 cleared submissions the average was 49 days from receipt to decision (median 54).
Which companies have the most OXD clearances?
W. L. Gore & Associates, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code OXD
- Run a recall and safety report across every OXD manufacturer
- Watch product code OXD 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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