K241333
- 510(k) number
- K241333
- Device name
- Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- Applicant
- Koh Young Technology, Inc. KR
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-01-17
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241333.pdf
Official FDA record: K241333
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.