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

[in effect]

United States · permit · permit

All Policies

Jurisdiction

United States

Classification

permit

Status

in effect

Effective Date

Jun 1, 2025

Primary Sources

1 audited

Statutory Scope & Summary

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.

Covered Sectors & Application Domains

Service & Cobot Robotics/

Regulatory Analysis & Inquiries

6 entries
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.

Primary Sources & Legal Instruments

1 document
  • https://www.futuremarketinsights.com/reports/neurosurgery-and-spine-robots-market

    https://www.futuremarketinsights.com/reports/neurosurgery-and-spine-robots-market

    Official Source