FDA product code GZD: Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
GZD is the FDA product code for stimulator, spinal-cord, implanted, for bladder evacuation. It is a Class III device, regulated under 21 CFR 882.5850 and reviewed by the Gastroenterology and Urology panel. Devices under GZD reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation |
| Device class | Class III |
| Regulation | 21 CFR 882.5850 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Neurology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for GZD devices
openFDA lists no recalls for product code GZD.
Frequently asked questions
What is FDA product code GZD?
GZD is the FDA product code for stimulator, spinal-cord, implanted, for bladder evacuation. It is a Class III device, regulated under 21 CFR 882.5850 and reviewed by the Gastroenterology and Urology panel.
What device class is GZD?
Class III, regulation 21 CFR 882.5850. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code GZD
- Run a recall and safety report across every GZD manufacturer
- Watch product code GZD 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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