FDA product code GXO: Strip, Craniosynostosis, Preformed
GXO is the FDA product code for strip, craniosynostosis, preformed. It is a Class II device, regulated under 21 CFR 882.5900 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under GXO, from 2 different applicants. The average 510(k) review took 104 days (median 104).
Classification
| Field | Value |
|---|---|
| Device name | Strip, Craniosynostosis, Preformed |
| Device class | Class II |
| Regulation | 21 CFR 882.5900 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every GXO clearance
Top GXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 1 | 2004-02-25 |
| W. L. Gore & Associates, Inc. | 1 | 1996-07-31 |
Most recent GXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033395 | Codman & Shurtleff, Inc. | CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 | 2004-02-25 | 125 |
| K961802 | W. L. Gore & Associates, Inc. | PRECLUDE SYNBLOC MEMBRANE | 1996-07-31 | 83 |
Recalls for GXO devices
openFDA lists no recalls for product code GXO.
Frequently asked questions
What is FDA product code GXO?
GXO is the FDA product code for strip, craniosynostosis, preformed. It is a Class II device, regulated under 21 CFR 882.5900 and reviewed by the Neurology panel.
What device class is GXO?
Class II, regulation 21 CFR 882.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXO?
Across 2 cleared submissions the average was 104 days from receipt to decision (median 104).
Which companies have the most GXO clearances?
Codman & Shurtleff, Inc. (1); W. L. Gore & Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GXO
- Run a recall and safety report across every GXO manufacturer
- Watch product code GXO 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times