FDA product code EZM: Dilator, Esophageal (Metal Olive) Gastro-Urology
EZM is the FDA product code for dilator, esophageal (metal olive) gastro-urology. It is a Class II device, regulated under 21 CFR 876.5365 and reviewed by the Gastroenterology and Urology panel. Devices under EZM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Esophageal (Metal Olive) Gastro-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.5365 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for EZM devices
openFDA lists no recalls for product code EZM.
Frequently asked questions
What is FDA product code EZM?
EZM is the FDA product code for dilator, esophageal (metal olive) gastro-urology. It is a Class II device, regulated under 21 CFR 876.5365 and reviewed by the Gastroenterology and Urology panel.
What device class is EZM?
Class II, regulation 21 CFR 876.5365. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EZM
- Run a recall and safety report across every EZM manufacturer
- Watch product code EZM 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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