SGE · Class II · 21 CFR 882.4560

FDA Product Code SGE: Extracranial Positional System For A Transcranial Magnetic Stimulation System

Intended For Spatial Positioning And Orientation Of The Treatment Coil For Transcutaneous Magnetic Stimulation Systems Under The Supervision Of A Tracking System.

Leading manufacturers include Zeta Surgical, Inc..

1
Total
1
Cleared
109d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Extracranial Positional System For A Transcranial Magnetic Stimulation System Devices (Product Code SGE)

1 devices
1–1 of 1
Cleared Oct 10, 2025
Zeta Navigation System (ZNS131-US)
K251927
Zeta Surgical, Inc.
Neurology · 109d

About Product Code SGE - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGE since 2025, with 1 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGE devices are reviewed by the Neurology panel. Browse all Neurology devices →