Zeta TMS Navigation System— 510(k) K261471

Substantially Equivalent

Zeta Surgical, Inc.

FDA 510(k) clearance K261471 for Zeta TMS Navigation System, Substantially Equivalent on 2026-07-09. Applicant: Zeta Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Zeta Surgical, Inc.
Product code: Code QFF
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2026-05-04
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFF

K182768 — TMS-Cobot TS MV2019-02-17

More clearances from Zeta Surgical, Inc.

K253663 — Zeta Navigation System2026-05-01
K251927 — Zeta Navigation System (ZNS131-US)2025-10-10
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.