Geniant Cranial (Navigated Neurosurgical Positioning Robot)

FDA 510(k) K253856 · Koh Young Technology, Inc.

Substantially Equivalent

510(k) numberK253856

Submission

Device name
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Applicant
Koh Young Technology, Inc.
Yeoju, KR
Received
December 3, 2025
Decision date
September 10, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

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Questions and answers

When was Geniant Cranial (Navigated Neurosurgical Positioning Robot) cleared by the FDA?

Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K253856) received a 510(k) decision of Substantially Equivalent on September 10, 2026, 281 days after the submission was received.

What is the product code of K253856?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.