FDA 510(k) clearance · back to tracker

Zeta TMS Navigation System

Zeta Surgical, Inc. cleared K261471 on 2026-07-09, decision: substantially equivalent

K-number

K261471

Sponsor

Zeta Surgical, Inc.

Device

Zeta TMS Navigation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-09

Product code

QFF

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.5805

Official FDA record

Open K261471on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.