Stereotaxic Guiding Surgical Devices, NaoTrac S— 510(k) K242575
Substantially EquivalentBrain Navi Biotechnology Co., Ltd.
FDA 510(k) clearance K242575 for Stereotaxic Guiding Surgical Devices, NaoTrac S, Substantially Equivalent on 2025-05-23. Applicant: Brain Navi Biotechnology Co., Ltd..
Clearance details
- Applicant
- Brain Navi Biotechnology Co., Ltd.
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu County, TW
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.