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FDA 510(k)

HandX Instrument - Monopolar Spatula

K-Number: K222011 · 2023-01-12

ApplicantHuman Xtensions , Ltd.
Decision Date2023-01-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HandX Instrument - Monopolar Spatula is the device name listed in this FDA 510(k) record. The listed applicant is Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2023-01-12 under 510(k) 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. The listed applicant is Human Xtensions , Ltd.. The 510(k) number is K222011.

When did HandX Instrument - Monopolar Spatula receive FDA 510(k) clearance?

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

Who is the listed applicant for HandX Instrument - Monopolar Spatula?

The FDA 510(k) record lists Human Xtensions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Human Xtensions , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223718HandX™ Self-Righting Needle HolderK230491HandX™ Monopolar ScissorsK212214HandXK203603Monopolar Hook

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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