FDA product code OXJ: Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
OXJ is the FDA product code for mesh, surgical, non-absorbable, large abdominal wall defects. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under OXJ, from 2 different applicants. The average 510(k) review took 254 days (median 254).
Definition
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects |
| 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 OXJ clearance
Top OXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Molnlycke Health Care Us, LLC | 1 | 2016-11-17 |
| Molnlycke Health Care | 1 | 2014-04-14 |
Most recent OXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161939 | Molnlycke Health Care Us, LLC | Avance Abdominal Dressing Kit | 2016-11-17 | 126 |
| K130852 | Molnlycke Health Care | AVANCE® FOAM ABDOMINAL DRESSING KIT | 2014-04-14 | 382 |
Recalls for OXJ devices
openFDA lists no recalls for product code OXJ.
Frequently asked questions
What is FDA product code OXJ?
OXJ is the FDA product code for mesh, surgical, non-absorbable, large abdominal wall defects. 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 OXJ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXJ?
Across 2 cleared submissions the average was 254 days from receipt to decision (median 254).
Which companies have the most OXJ clearances?
Molnlycke Health Care Us, LLC (1); Molnlycke Health Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXJ
- Run a recall and safety report across every OXJ manufacturer
- Watch product code OXJ 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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