FDA 510(k)

Monopolar Hook

K-Number: K203603 · 2021-02-01

Decision Date2021-02-01

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Monopolar Hook is a medical device manufactured by Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2021-02-01 under approval number K203603. 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 Monopolar Hook?

Monopolar Hook is a medical device that received FDA 510(k) clearance on 2021-02-01. It is manufactured by Human Xtensions , Ltd.. The 510(k) number is K203603.

When was Monopolar Hook approved by the FDA?

Monopolar Hook received FDA 510(k) clearance on 2021-02-01, under approval number K203603.

What company makes Monopolar Hook?

Monopolar Hook is manufactured by Human Xtensions , Ltd..

What is the FDA product code for Monopolar Hook?

The FDA product code for Monopolar Hook is GCJ.

Other Devices by Human Xtensions , Ltd.

K212214HandX 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.