FDA product code EZY: Device, Incontinence, Mechanical/Hydraulic
EZY is the FDA product code for device, incontinence, mechanical/hydraulic. It is a Class III device, regulated under 21 CFR 876.5280 and reviewed by the Gastroenterology and Urology panel. Devices under EZY reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 7 recalls for EZY devices, 3 initiated in the last five years.
Definition
PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
Classification
| Field | Value |
|---|---|
| Device name | Device, Incontinence, Mechanical/Hydraulic |
| Device class | Class III |
| Regulation | 21 CFR 876.5280 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for EZY devices
7 product recalls in 5 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2024-10-28.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code EZY?
EZY is the FDA product code for device, incontinence, mechanical/hydraulic. It is a Class III device, regulated under 21 CFR 876.5280 and reviewed by the Gastroenterology and Urology panel.
What device class is EZY?
Class III, regulation 21 CFR 876.5280. Typical premarket route: PMA.
Have EZY devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2024-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code EZY
- Run a recall and safety report across every EZY manufacturer
- Watch product code EZY 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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