FDA product code ERY: Drape, Surgical, Ent
ERY is the FDA product code for drape, surgical, ent. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. Devices under ERY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Drape, Surgical, Ent |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for ERY devices
openFDA lists no recalls for product code ERY.
Frequently asked questions
What is FDA product code ERY?
ERY is the FDA product code for drape, surgical, ent. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is ERY?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code ERY
- Run a recall and safety report across every ERY manufacturer
- Watch product code ERY 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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