K251927
- 510(k) number
- K251927
- Device name
- Zeta Navigation System (ZNS131-US)
- Applicant
- Zeta Surgical, Inc. MA · US
- Product code
- SGE — Extracranial Positional System For A Transcranial Ma
- Decision date
- 2025-10-10
- Date received
- 2025-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K251927.pdf
Official FDA record: K251927
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.