510(k) clearance
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- 510(k) number
- K253856
- Applicant
- Koh Young Technology, Inc.
- Decision date
- Sep 10, 2026
- Date received
- Dec 3, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HAW
- Device type
- Neurological Stereotaxic Instrument
- Device class
- Class II
- Regulation
- 21 CFR 882.4560
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Yeoju, KR