K233155
- 510(k) number
- K233155
- Device name
- ClearPointer Optical Navigation Wand
- Applicant
- ClearPoint Neuro, Inc. CA · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2024-01-12
- Date received
- 2023-09-27
- 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: K233155.pdf
Official FDA record: K233155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.