FDA 510(k)

GraftGun通用移植物输送系统（GDS）

K号: K243580 · 2025-02-05

决定日期2025-02-05

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

GraftGun Universal Graft Delivery System (GDS) is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K243580. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GraftGun Universal Graft Delivery System (GDS)?

GraftGun Universal Graft Delivery System (GDS) is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is SurGenTec, LLC. The 510(k) number is K243580.

When did GraftGun Universal Graft Delivery System (GDS) receive FDA 510(k) clearance?

GraftGun Universal Graft Delivery System (GDS) received FDA 510(k) clearance on 2025-02-05, under 510(k) number K243580.

Who is the listed applicant for GraftGun Universal Graft Delivery System (GDS)?

FDA 510(k)记录中列出SurGenTec, LLC为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for GraftGun Universal Graft Delivery System (GDS)?

The FDA product code for GraftGun Universal Graft Delivery System (GDS) is FMF.

列明SurGenTec, 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。

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相关器械（代码：FMF）

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

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。