FDA product code LXZ: Guard, Instrument
LXZ is the FDA product code for guard, instrument. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under LXZ, from 2 different applicants. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Guard, Instrument |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LXZ clearance
Top LXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sil-Med Corp. | 1 | 1996-01-23 |
| Devon Industries, Inc. | 1 | 1984-02-17 |
Most recent LXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955463 | Sil-Med Corp. | GRIP-A-BOOTS | 1996-01-23 | 55 |
| K834127 | Devon Industries, Inc. | INSTRUMENT TIP PROTECTION COVERS | 1984-02-17 | 80 |
Recalls for LXZ devices
openFDA lists no recalls for product code LXZ.
Frequently asked questions
What is FDA product code LXZ?
LXZ is the FDA product code for guard, instrument. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is LXZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LXZ?
Across 2 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most LXZ clearances?
Sil-Med Corp. (1); Devon Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXZ
- Run a recall and safety report across every LXZ manufacturer
- Watch product code LXZ 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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