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510(k) K241333

Geniant Cranial (Navigated Neurosurgical Positioning Robot) by KOH YOUNG TECHNOLOGY, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
May 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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