FDA product code MXW: Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
MXW is the FDA product code for suture, surgical, nonabsorbable, poly (vinylidene fluoride). It is a Class II device, regulated under 21 CFR 878.5010 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under MXW, from 2 different applicants. The average 510(k) review took 233 days (median 233).
Classification
| Field | Value |
|---|---|
| Device name | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) |
| Device class | Class II |
| Regulation | 21 CFR 878.5010 |
| 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 MXW clearance
Top MXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Peters Surgical | 1 | 2007-01-17 |
| ETHICON, Inc. | 1 | 2006-03-06 |
Most recent MXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060465 | Peters Surgical | PREMIO | 2007-01-17 | 329 |
| K052953 | ETHICON, Inc. | NUVANCE* FACIAL REJUVENATION SYSTEM | 2006-03-06 | 137 |
Recalls for MXW devices
openFDA lists no recalls for product code MXW.
Frequently asked questions
What is FDA product code MXW?
MXW is the FDA product code for suture, surgical, nonabsorbable, poly (vinylidene fluoride). It is a Class II device, regulated under 21 CFR 878.5010 and reviewed by the General and Plastic Surgery panel.
What device class is MXW?
Class II, regulation 21 CFR 878.5010. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXW?
Across 2 cleared submissions the average was 233 days from receipt to decision (median 233).
Which companies have the most MXW clearances?
Peters Surgical (1); ETHICON, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MXW
- Run a recall and safety report across every MXW manufacturer
- Watch product code MXW 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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