Zeta Navigation System (ZNS131-US)— 510(k) K251927

Name: FDA 510(k) clearance K251927
Creator: U.S. Food and Drug Administration
Published: 2025-10-10

Substantially Equivalent

Zeta Surgical, Inc.

FDA 510(k) clearance K251927 for Zeta Navigation System (ZNS131-US), Substantially Equivalent on 2025-10-10. Applicant: Zeta Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Zeta Surgical, Inc.
Product code: Code SGE
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-06-23
Decision date: 2025-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

More clearances from Zeta Surgical, Inc.

view all

K261471 — Zeta TMS Navigation System2026-07-09
K253663 — Zeta Navigation System2026-05-01
K242351 — Zeta Cranial Navigation System (ZNS131-US)2024-10-04
K233903 — Zeta Cranial Navigation System (ZNS131-US)2024-01-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.