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SGE

Extracranial Positional System For A Transcranial Magnetic Stimulation System

Product code
SGE
Device name
Extracranial Positional System For A Transcranial Magnetic Stimulation System
Device class
Class 2
21 CFR
21 CFR 882.4560
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-10.

NumberDecision dateApplicantDevice nameSummary
K2519272025-10-10Zeta Surgical, Inc.Zeta Navigation System (ZNS131-US)PDF

1 summaries are archived here for direct download.

Official FDA classification page: SGE
Classification and pathway per current FDA publications. Data from openFDA (CC0).