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FDA 510(k)

Xpan Universal Trocar System

K-Number: K223562 · 2023-06-02

ApplicantXpan, Inc.
Decision Date2023-06-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Xpan Universal Trocar System is the device name listed in this FDA 510(k) record. The listed applicant is Xpan, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K223562. 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 Xpan Universal Trocar System?

Xpan Universal Trocar System is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Xpan, Inc.. The 510(k) number is K223562.

When did Xpan Universal Trocar System receive FDA 510(k) clearance?

Xpan Universal Trocar System received FDA 510(k) clearance on 2023-06-02, under 510(k) number K223562.

Who is the listed applicant for Xpan Universal Trocar System?

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

What is the FDA product code for Xpan Universal Trocar System?

The FDA product code for Xpan Universal Trocar System is GCJ.

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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