FDA 510(k)

HandX

K-Number: K212214 · 2021-09-13

Decision Date2021-09-13

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HandX is a medical device manufactured by Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2021-09-13 under approval number K212214. 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?

HandX is a medical device that received FDA 510(k) clearance on 2021-09-13. It is manufactured by Human Xtensions , Ltd.. The 510(k) number is K212214.

When was HandX approved by the FDA?

HandX received FDA 510(k) clearance on 2021-09-13, under approval number K212214.

What company makes HandX?

HandX is manufactured by Human Xtensions , Ltd..

What is the FDA product code for HandX?

The FDA product code for HandX is GCJ.

Other Devices by Human Xtensions , Ltd.

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