FDA 510(k)

翻新 EndoWrist 长尖力爪 (420048)

K号: K250387 · 2025-08-19

决定日期2025-08-19

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 Long Tip Forceps (420048) is the device name listed in this FDA 510(k) record. The listed applicant is Rebotix. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K250387. 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 Long Tip Forceps (420048)?

Remanufactured EndoWrist Long Tip Forceps (420048) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Rebotix. The 510(k) number is K250387.

When did Remanufactured EndoWrist Long Tip Forceps (420048) receive FDA 510(k) clearance?

Remanufactured EndoWrist Long Tip Forceps (420048) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K250387.

Who is the listed applicant for Remanufactured EndoWrist Long Tip Forceps (420048)?

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 Long Tip Forceps (420048)?

The FDA product code for Remanufactured EndoWrist Long Tip Forceps (420048) is QSM.

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。

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官方来源

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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。