510(k) K251927

Device

Zeta Navigation System (ZNS131-US)

Applicant

Zeta Surgical, Inc.

510(k) number

K251927

Product code

SGE

Decision

Substantially Equivalent (SESE)

Decision date

2025-10-10

Date received

2025-06-23

Regulation

882.4560

Classification name

Extracranial Positional System For A Transcranial Magnetic Stimulation System

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Special

Statement or summary

Summary

Third party reviewed

N