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FDA 510(k)

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

K-Number: K253856 · 2026-09-10

ApplicantKoh Young Technology, Inc.
Decision Date2026-09-10
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Geniant Cranial (Navigated Neurosurgical Positioning Robot) is the device name listed in this FDA 510(k) record. The listed applicant is Koh Young Technology, Inc.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K253856. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geniant Cranial (Navigated Neurosurgical Positioning Robot)?

Geniant Cranial (Navigated Neurosurgical Positioning Robot) is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Koh Young Technology, Inc.. The 510(k) number is K253856.

When did Geniant Cranial (Navigated Neurosurgical Positioning Robot) receive FDA 510(k) clearance?

Geniant Cranial (Navigated Neurosurgical Positioning Robot) received FDA 510(k) clearance on 2026-09-10, under 510(k) number K253856.

Who is the listed applicant for Geniant Cranial (Navigated Neurosurgical Positioning Robot)?

The FDA 510(k) record lists Koh Young Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geniant Cranial (Navigated Neurosurgical Positioning Robot)?

The FDA product code for Geniant Cranial (Navigated Neurosurgical Positioning Robot) is HAW.

Other records listing Koh Young Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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