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FDA 510(k)

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

K-Number: K241333 · 2025-01-17

ApplicantKoh Young Technology, Inc.
Decision Date2025-01-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Geniant Cranial (Navigated Neurosurgical Positioning Robot) is a medical device manufactured by Koh Young Technology, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K241333. 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 2025-01-17. It is manufactured by Koh Young Technology, Inc.. The 510(k) number is K241333.

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

Geniant Cranial (Navigated Neurosurgical Positioning Robot) received FDA 510(k) clearance on 2025-01-17, under approval number K241333.

What company makes Geniant Cranial (Navigated Neurosurgical Positioning Robot)?

Geniant Cranial (Navigated Neurosurgical Positioning Robot) is manufactured by Koh Young Technology, Inc..

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.

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Official Source

View on FDA Database →

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

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