FDA 510(k)

HandX Instrument - Monopolar Spatula

K-Number: K222011 · 2023-01-12

Decision Date2023-01-12

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HandX Instrument - Monopolar Spatula is a medical device manufactured by Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2023-01-12 under approval number K222011. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HandX Instrument - Monopolar Spatula?

HandX Instrument - Monopolar Spatula is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Human Xtensions , Ltd.. The 510(k) number is K222011.

When was HandX Instrument - Monopolar Spatula approved by the FDA?

HandX Instrument - Monopolar Spatula received FDA 510(k) clearance on 2023-01-12, under approval number K222011.

What company makes HandX Instrument - Monopolar Spatula?

HandX Instrument - Monopolar Spatula is manufactured by Human Xtensions , Ltd..

What is the FDA product code for HandX Instrument - Monopolar Spatula?

The FDA product code for HandX Instrument - Monopolar Spatula is GCJ.

Other Devices by Human Xtensions , Ltd.

K212214HandX K203603Monopolar Hook K223718HandX Self-Righting Needle Holder K230491HandX Monopolar Scissors

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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.