FDA product code EWT: Device, Antichoke, Suction
EWT is the FDA product code for device, antichoke, suction. It is a Class III device, regulated under 21 CFR 874.5350 and reviewed by the Ear, Nose and Throat panel. Devices under EWT reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs on 7/13/99 per 64 FR 18329 on 4/14/99
Classification
| Field | Value |
|---|---|
| Device name | Device, Antichoke, Suction |
| Device class | Class III |
| Regulation | 21 CFR 874.5350 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | PMA |
Recalls for EWT devices
openFDA lists no recalls for product code EWT.
Frequently asked questions
What is FDA product code EWT?
EWT is the FDA product code for device, antichoke, suction. It is a Class III device, regulated under 21 CFR 874.5350 and reviewed by the Ear, Nose and Throat panel.
What device class is EWT?
Class III, regulation 21 CFR 874.5350. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code EWT
- Run a recall and safety report across every EWT manufacturer
- Watch product code EWT 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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