无刀Trocar – Artemis腹腔镜套管
K号: K231400 · 2023-08-04
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决定日期2023-08-04
产品代码GCJ
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Bladeless Trocar – Artemis Lap Cannula is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K231400. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bladeless Trocar – Artemis Lap Cannula?
Bladeless Trocar – Artemis Lap Cannula is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K231400.
When did Bladeless Trocar – Artemis Lap Cannula receive FDA 510(k) clearance?
Bladeless Trocar – Artemis Lap Cannula received FDA 510(k) clearance on 2023-08-04, under 510(k) number K231400.
Who is the listed applicant for Bladeless Trocar – Artemis Lap Cannula?
FDA 510(k)记录将T.A.G. Medical Products Corporation, Ltd.列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Bladeless Trocar – Artemis Lap Cannula?
The FDA product code for Bladeless Trocar – Artemis Lap Cannula is GCJ.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明T.A.G. Medical Products Corporation, Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GCJ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE选择系统Karl Storz SE & CO. KGK260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony CorporationK261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLCK253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical ImpactK261614LED液晶显示器（OEV-271H）Lg Electronics.Inc
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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