K241327
- 510(k) number
- K241327
- Device name
- Navient Image Guide Navigation System (955-NC-NC), Cranial
- Applicant
- Claronav CA
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-02-05
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K241327.pdf
Official FDA record: K241327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.