FDA product code OXE: Mesh, Surgical, Collagen, Staple Line Reinforcement
OXE is the FDA product code for mesh, surgical, collagen, 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 4 510(k) submissions under OXE, from 4 different applicants. The average 510(k) review took 99 days (median 48).
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Collagen, 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 OXE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
Compare with all 510(k) review times · Search every OXE clearance
Top OXE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Biotech Incorporated | 1 | 2017-04-28 |
| Kerecis Limited | 1 | 2016-08-19 |
| Synovis Surgical Innovations | 1 | 2003-04-24 |
| Cook Biotech, Inc. | 1 | 2002-08-23 |
Most recent OXE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170945 | Cook Biotech Incorporated | Biodesign Staple Line Reinforcement | 2017-04-28 | 29 |
| K153364 | Kerecis Limited | Kerecis SecureMesh | 2016-08-19 | 273 |
| K030879 | Synovis Surgical Innovations | VERITAS COLLAGEN MATRIX | 2003-04-24 | 35 |
| K022044 | Cook Biotech, Inc. | SURGISIS STAPLE LINE REINFORCEMENT | 2002-08-23 | 60 |
Recalls for OXE devices
openFDA lists no recalls for product code OXE.
Frequently asked questions
What is FDA product code OXE?
OXE is the FDA product code for mesh, surgical, collagen, 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 OXE?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXE?
Across 4 cleared submissions the average was 99 days from receipt to decision (median 48).
Which companies have the most OXE clearances?
Cook Biotech Incorporated (1); Kerecis Limited (1); Synovis Surgical Innovations (1); Cook Biotech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXE
- Run a recall and safety report across every OXE manufacturer
- Watch product code OXE 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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