Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology, Inc. · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Yeoju
- Advisory committee description
- Neurology
- Address 1
- 1f, 66-27, Gwangdae 2-Gil, Sejongdaewang-Myeon, Yeoju-Si
- Statement or summary
- Summary
- Product code
- HAW
- Zip code
- 12647
- Applicant
- Koh Young Technology, Inc.
- Decision date
- 2026-09-10
- Decision code
- SESE
- Country code
- KR
- Device name
- Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- Advisory committee
- NE
- Contact
- Sooji Shin
- K number
- K253856
- Date received
- 2025-12-03
- Review advisory committee
- NE
- Postal code
- 12647
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Neurological Stereotaxic Instrument
- Medical specialty description
- Neurology
- Regulation number
- 882.4560
- Device class
- 2
- Registration number
- 1723170, 3010209365, 3013176080, 9611894, 3008627763, 3017210488, 3021632375, 3009829742, 3027375826, 1834331, 9617544, 3010047454, 3009185973, 1225492, 3010462278, 3007539489, 3012447612, 3005061536, 3006405073, 3005075696, 2183456, 9710332, 8039051, 1824206, 3013726944, 2182979, 3030733800, 3009555447, 3010120326, 1833920, 3021591288, 3008110533, 3012322232, 1048735, 1226188, 3009144915, 3015131155, 3015536273, 1450662, 3009538961 +212 more
- FEI number
- 3010209365, 3002980729, 3002806315, 5638, 3013176080, 3008627763, 3002807464, 3017210488, 3021632375, 3003714383, 3009829742, 3027375826, 3010047454, 3009185973, 3010462278, 3007539489, 3012447612, 3005061536, 3006405073, 3005075696, 2183456, 1824206, 3003251135, 3013726944, 2182979, 3030733800, 3009555447, 3010120326, 3021591288, 3008110533, 3012322232, 1048735, 3005154439, 3009144915, 3015131155, 3015536273, 1450662, 3009538961, 3006128100, 3002808157 +212 more