FDA product code JYW: Press, Vein
JYW is the FDA product code for press, vein. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under JYW. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Press, Vein |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Top JYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 1 | 1982-09-09 |
Most recent JYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822368 | Treace Medical, Inc. | CALIBRATED TISSUE GRAFT PRESS | 1982-09-09 | 34 |
Recalls for JYW devices
openFDA lists no recalls for product code JYW.
Frequently asked questions
What is FDA product code JYW?
JYW is the FDA product code for press, vein. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is JYW?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYW?
Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most JYW clearances?
Treace Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYW
- Run a recall and safety report across every JYW manufacturer
- Watch product code JYW 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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