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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 K253856
Device Name Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Applicant
Koh Young Technology, Inc.
1f, 66-27, Gwangdae 2-Gil, Sejongdaewang-Myeon, Yeoju-Si
Yeoju,  KR 12647
Applicant Contact Sooji Shin
Correspondent
Koh Young Technology, Inc.
1f, 66-27, Gwangdae 2-Gil, Sejongdaewang-Myeon, Yeoju-Si
Yeoju,  KR 12647
Correspondent Contact Sooji Shin
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/03/2025
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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