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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K241333
Device Name Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Applicant
Koh Young Technology, Inc.
1f, 66-27, Gwangdae 2-Gil, Sejongdaewang-Myeon, Yeoju-Si
Gyeonggi-Do,  KR
Applicant Contact Sooji Shin
Correspondent
Koh Young Technology, Inc.
1f, 66-27, Gwangdae 2-Gil, Sejongdaewang-Myeon, Yeoju-Si
Gyeonggi-Do,  KR
Correspondent Contact Sooji Shin
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/10/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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