FDA product code LZM: Guard, Skin Graft
LZM is the FDA product code for guard, skin graft. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under LZM, from 2 different applicants. The average 510(k) review took 53 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Guard, Skin Graft |
| Device class | Class I |
| Regulation | 21 CFR 878.4014 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LZM clearance
Top LZM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wfr/Aquaplast Corp. | 1 | 1994-09-30 |
| Sorex Medical | 1 | 1989-02-06 |
Most recent LZM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943871 | Wfr/Aquaplast Corp. | AQUAPLAST TIE DOWN DRESSING | 1994-09-30 | 53 |
| K885136 | Sorex Medical | GRAFT GUARD | 1989-02-06 | 53 |
Recalls for LZM devices
openFDA lists no recalls for product code LZM.
Frequently asked questions
What is FDA product code LZM?
LZM is the FDA product code for guard, skin graft. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel.
What device class is LZM?
Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LZM?
Across 2 cleared submissions the average was 53 days from receipt to decision (median 53).
Which companies have the most LZM clearances?
Wfr/Aquaplast Corp. (1); Sorex Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LZM
- Run a recall and safety report across every LZM manufacturer
- Watch product code LZM 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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