FDA product code SDG: Brain Intraparenchymal Infusion Cannula
SDG is the FDA product code for brain intraparenchymal infusion cannula. It is a Class II device, regulated under 21 CFR 882.4110 and reviewed by the Neurology panel. Devices under SDG reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy.
Classification
| Field | Value |
|---|---|
| Device name | Brain Intraparenchymal Infusion Cannula |
| Device class | Class II |
| Regulation | 21 CFR 882.4110 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SDG devices
openFDA lists no recalls for product code SDG.
Frequently asked questions
What is FDA product code SDG?
SDG is the FDA product code for brain intraparenchymal infusion cannula. It is a Class II device, regulated under 21 CFR 882.4110 and reviewed by the Neurology panel.
What device class is SDG?
Class II, regulation 21 CFR 882.4110. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SDG
- Run a recall and safety report across every SDG manufacturer
- Watch product code SDG 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.