FDA product code OWV: Mesh, Surgical, Collagen, Diaphragmatic Hernia
OWV is the FDA product code for mesh, surgical, collagen, diaphragmatic hernia. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under OWV. The average 510(k) review took 268 days (median 268). FDA has posted 1 recall for OWV devices, 1 initiated in the last five years.
Definition
For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Collagen, Diaphragmatic Hernia |
| 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 OWV clearance
Top OWV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Biotech, Inc. | 1 | 2014-06-20 |
Most recent OWV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133011 | Cook Biotech, Inc. | DIAPHRAGMATIC HERNIA GRAFT | 2014-06-20 | 268 |
Recalls for OWV devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-11-22.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code OWV?
OWV is the FDA product code for mesh, surgical, collagen, diaphragmatic hernia. 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 OWV?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWV?
Across 1 cleared submissions the average was 268 days from receipt to decision (median 268).
Which companies have the most OWV clearances?
Cook Biotech, Inc. (1).
Have OWV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code OWV
- Run a recall and safety report across every OWV manufacturer
- Watch product code OWV 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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