FDA 510(k)

HandX Self-Righting Needle Holder

K-Number: K223718 · 2023-06-05

Decision Date2023-06-05

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HandX Self-Righting Needle Holder is a medical device manufactured by Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2023-06-05 under approval number K223718. 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 Self-Righting Needle Holder?

HandX Self-Righting Needle Holder is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Human Xtensions , Ltd.. The 510(k) number is K223718.

When was HandX Self-Righting Needle Holder approved by the FDA?

HandX Self-Righting Needle Holder received FDA 510(k) clearance on 2023-06-05, under approval number K223718.

What company makes HandX Self-Righting Needle Holder?

HandX Self-Righting Needle Holder is manufactured by Human Xtensions , Ltd..

What is the FDA product code for HandX Self-Righting Needle Holder?

The FDA product code for HandX Self-Righting Needle Holder is GCJ.

Other Devices by Human Xtensions , Ltd.

K212214HandX K203603Monopolar Hook 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.