SGE — Extracranial Positional System For A Transcranial Magnetic Stimulation System Class II
FDA product code SGE covers "Extracranial Positional System For A Transcranial Magnetic Stimulation System", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGE
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251927 | zeta surgical | Zeta Navigation System (ZNS131-US) | October 10, 2025 |