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FDA 510(k)

翻新 EndoWrist ProGrasp 力爪 (420093)

K号: K241872 · 2024-11-07

申请人Rebotix
决定日期2024-11-07
产品代码QSM
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

Remanufactured EndoWrist ProGrasp Forceps (420093) is the device name listed in this FDA 510(k) record. The listed applicant is Rebotix. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K241872. The device is classified under product code QSM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Remanufactured EndoWrist ProGrasp Forceps (420093)?

Remanufactured EndoWrist ProGrasp Forceps (420093) is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Rebotix. The 510(k) number is K241872.

When did Remanufactured EndoWrist ProGrasp Forceps (420093) receive FDA 510(k) clearance?

Remanufactured EndoWrist ProGrasp Forceps (420093) received FDA 510(k) clearance on 2024-11-07, under 510(k) number K241872.

Who is the listed applicant for Remanufactured EndoWrist ProGrasp Forceps (420093)?

The FDA 510(k) record lists Rebotix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remanufactured EndoWrist ProGrasp Forceps (420093)?

The FDA product code for Remanufactured EndoWrist ProGrasp Forceps (420093) is QSM.

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Rebotix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:QSM)

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。

官方来源

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