FDA 510(k)

翻新 EndoWrist Cobra 把手 (420190)

K号: K250417 · 2025-08-20

决定日期2025-08-20

产品代码QSM

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决定实质等同

器械摘要

Remanufactured EndoWrist Cobra Grasper (420190) is the device name listed in this FDA 510(k) record. The listed applicant is Rebotix. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K250417. 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 Cobra Grasper (420190)?

Remanufactured EndoWrist Cobra Grasper (420190) is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Rebotix. The 510(k) number is K250417.

When did Remanufactured EndoWrist Cobra Grasper (420190) receive FDA 510(k) clearance?

Remanufactured EndoWrist Cobra Grasper (420190) received FDA 510(k) clearance on 2025-08-20, under 510(k) number K250417.

Who is the listed applicant for Remanufactured EndoWrist Cobra Grasper (420190)?

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 Cobra Grasper (420190)?

The FDA product code for Remanufactured EndoWrist Cobra Grasper (420190) 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。

K250399翻新 EndoWrist Cadiere 力爪 (420049)K250387翻新 EndoWrist 长尖力爪 (420048)K250539翻新 EndoWrist 十字钳力爪 (420207)K241872翻新 EndoWrist ProGrasp 力爪 (420093)

官方来源

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