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The Tracker / September 2026 / K253856

510(k) cleared

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Koh Young Technology, Inc. · Sep 10, 2026 · K253856

FDA cleared the Geniant Cranial (Navigated Neurosurgical Positioning Robot) from Koh Young Technology, Inc. on Sep 10, 2026 under K253856, a traditional 510(k). The device falls under product code HAW, Neurological Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 3, 2025. The decision came 281 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Koh Young Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253856?

K253856 is the FDA 510(k) for Geniant Cranial (Navigated Neurosurgical Positioning Robot), submitted by Koh Young Technology, Inc.. FDA's decision date was Sep 10, 2026, under product code HAW (Neurological Stereotaxic Instrument).

Who makes the Geniant Cranial (Navigated Neurosurgical Positioning Robot)?

Koh Young Technology, Inc., based in Yeoju, is the applicant of record for K253856.

How long did the K253856 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Sep 10, 2026, 281 days later.

← All decisions in September 2026