FDA product code SGN: High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
SGN is the FDA product code for high intensity focused ultrasound system for peripheral neural tissue ablation. It is a Class II device, regulated under 21 CFR 882.4420 and reviewed by the Neurology panel. Devices under SGN 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 high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling.
Classification
| Field | Value |
|---|---|
| Device name | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation |
| Device class | Class II |
| Regulation | 21 CFR 882.4420 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SGN devices
openFDA lists no recalls for product code SGN.
Frequently asked questions
What is FDA product code SGN?
SGN is the FDA product code for high intensity focused ultrasound system for peripheral neural tissue ablation. It is a Class II device, regulated under 21 CFR 882.4420 and reviewed by the Neurology panel.
What device class is SGN?
Class II, regulation 21 CFR 882.4420. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SGN
- Run a recall and safety report across every SGN manufacturer
- Watch product code SGN 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.