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 positioning robot for neurosurgery from Koh Young Technology. It's filed under HAW, neurological stereotaxic instruments, the code for systems that guide instruments to a planned target in the brain using the patient's imaging. Koh Young is best known for 3D inspection equipment in electronics manufacturing, so this is a move outside its main business.
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). Surgical robots get a lot of scrutiny on accuracy and software, and a nine-month review isn't unusual for one.
Clearance details
- Applicant
- Koh Young Technology, Inc.
- Product code
- 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.