Product Code: SGE
FDA class 2
21 CFR 882.4560
Extracranial Positional System For A Transcranial Magnetic Stimulation System
Neurology
510(k)s
1
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SGE
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251927 | Zeta Navigation System (ZNS131-US) | Oct 10, 2025 | Substantially Equivalent | Zeta Surgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.