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 a medical device manufactured by Xpan, Inc.. It received FDA 510(k) clearance on 2023-06-02 under approval 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. It is manufactured by Xpan, Inc.. The 510(k) number is K223562.
When was Xpan Universal Trocar System approved by the FDA?
Xpan Universal Trocar System received FDA 510(k) clearance on 2023-06-02, under approval number K223562.
What company makes Xpan Universal Trocar System?
Xpan Universal Trocar System is manufactured by Xpan, Inc..
What is the FDA product code for Xpan Universal Trocar System?
The FDA product code for Xpan Universal Trocar System is GCJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.