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Regulation · Permit

FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot

Brain Navi received FDA 510(k) clearance for NaoTrac as a stereotaxic guiding surgical device for neurosurgery, enabling robot-guided precision in brain surgery procedures.

Jurisdiction: United States · Effective 2025-06-01

Machine-readable surfaces

Sources (1)

  1. https://www.futuremarketinsights.com/reports/neurosurgery-and-spine-robots-market · 2025-06-01

Status history

  • In effect · 2025-06-01 · agent-recon

    Initial ingestion

Common questions

What does FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot cover?
Brain Navi received FDA 510(k) clearance for NaoTrac as a stereotaxic guiding surgical device for neurosurgery, enabling robot-guided precision in brain surgery procedures.
Where does FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot apply?
FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot is recorded as a permitting requirement applying in United States on the DEPLOY registry.
When did FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot take effect?
FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot is recorded as effective June 1, 2025 on the DEPLOY registry.
Is FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot still in effect?
FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot apply to?
FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot is recorded as applying to surgical on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot?
8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA 510(k) Clearance: Brain Navi NaoTrac Stereotaxic Surgical Robot.

Canonical ID 4b7ee156-da2e-438b-9d5f-fec13fe980dd