FDA product code GZC: Stimulator, Neuromuscular, Implanted
GZC is the FDA product code for stimulator, neuromuscular, implanted. It is a Class III device, regulated under 21 CFR 882.5860 and reviewed by the Physical Medicine panel. Devices under GZC reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for GZC devices.
Definition
Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Neuromuscular, Implanted |
| Device class | Class III |
| Regulation | 21 CFR 882.5860 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Neurology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for GZC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-08-17.
Frequently asked questions
What is FDA product code GZC?
GZC is the FDA product code for stimulator, neuromuscular, implanted. It is a Class III device, regulated under 21 CFR 882.5860 and reviewed by the Physical Medicine panel.
What device class is GZC?
Class III, regulation 21 CFR 882.5860. Typical premarket route: PMA.
Have GZC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-08-17.
Next steps
- Run an FDA pathway report with predicate devices for product code GZC
- Run a recall and safety report across every GZC manufacturer
- Watch product code GZC 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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