FDA product code LYV: Label Or Tag, Sterile
LYV is the FDA product code for label or tag, sterile. 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 LYV. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Label Or Tag, Sterile |
| 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 |
Compare with all 510(k) review times · Search every LYV clearance
Top LYV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acacia Laboratories, Inc. | 2 | 1988-10-13 |
Most recent LYV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884055 | Acacia Laboratories, Inc. | SURGI-TAG(TM) STERILE LABEL SETS | 1988-10-13 | 17 |
| K883654 | Acacia Laboratories, Inc. | STERI-TAG(TM) STERILE LABEL SETS | 1988-10-13 | 48 |
Recalls for LYV devices
openFDA lists no recalls for product code LYV.
Frequently asked questions
What is FDA product code LYV?
LYV is the FDA product code for label or tag, sterile. 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 LYV?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYV?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most LYV clearances?
Acacia Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LYV
- Run a recall and safety report across every LYV manufacturer
- Watch product code LYV 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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