Geniant Cranial (Navigated Neurosurgical Positioning Robot)— 510(k) K253856
Substantially EquivalentKoh Young Technology, Inc.
FDA 510(k) clearance K253856 for Geniant Cranial (Navigated Neurosurgical Positioning Robot), Substantially Equivalent on 2026-09-10. Applicant: Koh Young Technology, Inc.. Device class: 2.
Summary
Geniant Cranial is a navigated neurosurgical positioning robot from Koh Young Technology, going by the device name. It's filed under HAW, neurological stereotaxic instruments.
Class II, 21 CFR 882.4560. The Neurology panel reviewed it as a Traditional 510(k).
The company filed from Yeoju, South Korea. Review took 281 days (December 3, 2025 to September 10, 2026).
Clearance details
- Applicant
- Koh Young Technology, Inc.
- Product code
- Product code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yeoju, KR
Recent devices under product code HAW
view allMore clearances from Koh Young Technology, Inc.
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.