FDA 510(k)

Boehringer Laboratories肝脏拉钩

K号: K243399 · 2025-07-02

决定日期2025-07-02

产品代码GCJ

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决定实质等同

器械摘要

Boehringer Laboratories Liver Retractor is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories, LLC. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K243399. 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 Boehringer Laboratories Liver Retractor?

Boehringer Laboratories Liver Retractor is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Boehringer Laboratories, LLC. The 510(k) number is K243399.

When did Boehringer Laboratories Liver Retractor receive FDA 510(k) clearance?

Boehringer Laboratories Liver Retractor received FDA 510(k) clearance on 2025-07-02, under 510(k) number K243399.

Who is the listed applicant for Boehringer Laboratories Liver Retractor?

FDA 510(k)记录显示，Boehringer Laboratories, LLC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 Boehringer Laboratories Liver Retractor?

The FDA product code for Boehringer Laboratories Liver Retractor is GCJ.

列明Boehringer Laboratories, LLC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。

K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®K234033ViSiGi LUX（5332）；ViSiGi LUX（5336）；ViSiGi LUX（5340）

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。

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官方来源

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