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510(k) K251927

Zeta Navigation System (ZNS131-US) by Zeta Surgical, Inc. — Product Code SGE

K251927 is an FDA 510(k) premarket notification submitted by Zeta Surgical, Inc. for the device "Zeta Navigation System (ZNS131-US)". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code SGE (Extracranial Positional System For A Transcranial Magnetic Stimulation System), a Class II device regulated under 21 CFR 882.4560. Zeta Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
June 23, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracranial Positional System For A Transcranial Magnetic Stimulation System
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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

Other clearances by Zeta Surgical, Inc.

  • K261471 — Zeta TMS Navigation System (July 9, 2026)
  • K253663 — Zeta Navigation System (May 1, 2026)
  • K242351 — Zeta Cranial Navigation System (ZNS131-US) (October 4, 2024)
  • K233903 — Zeta Cranial Navigation System (ZNS131-US) (January 10, 2024)
  • K230661 — Zeta Cranial Navigation System (September 8, 2023)

FDA data resources