FDA product code OXK: Mesh, Surgical, Collagen, Large Abdominal Wall Defects
OXK is the FDA product code for mesh, surgical, collagen, 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 OXK. The average 510(k) review took 59 days (median 59).
Definition
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Collagen, 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 OXK clearance
Top OXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lifecell Corp. | 2 | 2013-04-17 |
Most recent OXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130817 | Lifecell Corp. | LTN - LAPAROSCOPIC SURGICAL MESH | 2013-04-17 | 23 |
| K121289 | Lifecell Corp. | LTM-LABAROSCOPIC SURGICAL MESH | 2012-08-03 | 95 |
Recalls for OXK devices
openFDA lists no recalls for product code OXK.
Frequently asked questions
What is FDA product code OXK?
OXK is the FDA product code for mesh, surgical, collagen, 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 OXK?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXK?
Across 2 cleared submissions the average was 59 days from receipt to decision (median 59).
Which companies have the most OXK clearances?
Lifecell Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OXK
- Run a recall and safety report across every OXK manufacturer
- Watch product code OXK 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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