FDA product code JYH: Excavator, Ear
JYH is the FDA product code for excavator, ear. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under JYH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Excavator, Ear |
| 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 |
Recalls for JYH devices
openFDA lists no recalls for product code JYH.
Frequently asked questions
What is FDA product code JYH?
JYH is the FDA product code for excavator, ear. 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 JYH?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JYH
- Run a recall and safety report across every JYH manufacturer
- Watch product code JYH 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times