FDA 510(k)

Inno-Port 一次性无刀片式套管，Inno-Port 一次性光学套管

K号: K223593 · 2023-03-22

决定日期2023-03-22

产品代码GCJ

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决定实质等同

器械摘要

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Surgical Corporation. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K223593. 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 Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Taiwan Surgical Corporation. The 510(k) number is K223593.

When did Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar receive FDA 510(k) clearance?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar received FDA 510(k) clearance on 2023-03-22, under 510(k) number K223593.

Who is the listed applicant for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

FDA 510(k)记录显示台湾外科股份有限公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

The FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is GCJ.

列明Taiwan Surgical Corporation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。

K252535Inno-Switch™ 腹腔镜器械 K254231Inno-Hook™ 一次性夹子应用器（结扎夹）和 Inno-Hook™ 结扎夹 K252532Inno-Port 一次性刀片式套管 K253903InnoClip 一次性套管夹应用器 K253781InnoClip 套管夹应用器 K202994InnoClip 一次性套管夹应用器，InnoClip 套管夹应用器

查看所有 7 个设备 →

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 Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-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 Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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