_Regulation · Permit_

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

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

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2025-06-01

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.

## 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.


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