FDA product code SGE: Extracranial Positional System For A Transcranial Magnetic Stimulation System
SGE is the FDA product code for extracranial positional system for a transcranial magnetic stimulation system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SGE, 1 in the last five years. The average 510(k) review took 109 days (median 109); 109 days on average over the last three years.
Definition
Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
Classification
| Field | Value |
|---|---|
| Device name | Extracranial Positional System For A Transcranial Magnetic Stimulation System |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for SGE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 109 |
Compare with all 510(k) review times · Search every SGE clearance
Top SGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeta Surgical, Inc. | 1 | 2025-10-10 |
Most recent SGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251927 | Zeta Surgical, Inc. | Zeta Navigation System (ZNS131-US) | 2025-10-10 | 109 |
Recalls for SGE devices
openFDA lists no recalls for product code SGE.
Frequently asked questions
What is FDA product code SGE?
SGE is the FDA product code for extracranial positional system for a transcranial magnetic stimulation system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel.
What device class is SGE?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGE?
Across 1 cleared submissions the average was 109 days from receipt to decision (median 109).
Which companies have the most SGE clearances?
Zeta Surgical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGE
- Run a recall and safety report across every SGE manufacturer
- Watch product code SGE 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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