K242575
- 510(k) number
- K242575
- Device name
- Stereotaxic Guiding Surgical Devices, NaoTrac S
- Applicant
- Brain Navi Biotechnology Co., Ltd. TW
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-05-23
- Date received
- 2024-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242575.pdf
Official FDA record: K242575
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.