FDA 510(k)

HandX Monopolar Scissors

K-Number: K230491 · 2023-05-10

Decision Date2023-05-10

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HandX Monopolar Scissors is a medical device manufactured by Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2023-05-10 under approval number K230491. 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 Monopolar Scissors?

HandX Monopolar Scissors is a medical device that received FDA 510(k) clearance on 2023-05-10. It is manufactured by Human Xtensions , Ltd.. The 510(k) number is K230491.

When was HandX Monopolar Scissors approved by the FDA?

HandX Monopolar Scissors received FDA 510(k) clearance on 2023-05-10, under approval number K230491.

What company makes HandX Monopolar Scissors?

HandX Monopolar Scissors is manufactured by Human Xtensions , Ltd..

What is the FDA product code for HandX Monopolar Scissors?

The FDA product code for HandX Monopolar Scissors is GCJ.

Other Devices by Human Xtensions , Ltd.

K212214HandX K203603Monopolar Hook K223718HandX Self-Righting Needle Holder K222011HandX Instrument - Monopolar Spatula

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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.