Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → SGE — Extracranial Positional System For A Transcranial Magnetic Stimulation System

# SGE · Extracranial Positional System For A Transcranial Magnetic Stimulation System

_Neurology · 21 CFR 882.4560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SGE

## Overview

- **Product Code:** SGE
- **Device Name:** Extracranial Positional System For A Transcranial Magnetic Stimulation System
- **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251927](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SGE/K251927.md) | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | Oct 10, 2025 | SESE |

## Top Applicants

- Zeta Surgical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SGE](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SGE)

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