FDA product code GYZ: Stimulator, Intracerebral/Subcortical, Implanted
GYZ is the FDA product code for stimulator, intracerebral/subcortical, implanted. It is a Class III device, regulated under 21 CFR 882.5840 and reviewed by the Neurology panel. Devices under GYZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Intracerebral/Subcortical, Implanted |
| Device class | Class III |
| Regulation | 21 CFR 882.5840 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for GYZ devices
openFDA lists no recalls for product code GYZ.
Frequently asked questions
What is FDA product code GYZ?
GYZ is the FDA product code for stimulator, intracerebral/subcortical, implanted. It is a Class III device, regulated under 21 CFR 882.5840 and reviewed by the Neurology panel.
What device class is GYZ?
Class III, regulation 21 CFR 882.5840. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code GYZ
- Run a recall and safety report across every GYZ manufacturer
- Watch product code GYZ 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times