FDA product code EZW: Stimulator, Electrical, Implantable, For Incontinence
EZW is the FDA product code for stimulator, electrical, implantable, for incontinence. It is a Class III device, regulated under 21 CFR 876.5270 and reviewed by the Gastroenterology and Urology panel. Devices under EZW reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 9 recalls for EZW devices, 5 initiated in the last five years.
Definition
PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Implantable, For Incontinence |
| Device class | Class III |
| Regulation | 21 CFR 876.5270 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for EZW devices
9 product recalls in 9 recall events; 5 initiated in the last five years and 6 still open. Most recent: 2025-04-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
Frequently asked questions
What is FDA product code EZW?
EZW is the FDA product code for stimulator, electrical, implantable, for incontinence. It is a Class III device, regulated under 21 CFR 876.5270 and reviewed by the Gastroenterology and Urology panel.
What device class is EZW?
Class III, regulation 21 CFR 876.5270. Typical premarket route: PMA.
Have EZW devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2025-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code EZW
- Run a recall and safety report across every EZW manufacturer
- Watch product code EZW 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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