FDA 510(k)

翻新 EndoWrist Cadiere 力爪 (420049)

K号: K250399 · 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 Cadiere Forceps (420049) 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 K250399. 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 Cadiere Forceps (420049)?

Remanufactured EndoWrist Cadiere Forceps (420049) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Rebotix. The 510(k) number is K250399.

When did Remanufactured EndoWrist Cadiere Forceps (420049) receive FDA 510(k) clearance?

Remanufactured EndoWrist Cadiere Forceps (420049) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K250399.

Who is the listed applicant for Remanufactured EndoWrist Cadiere Forceps (420049)?

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 Cadiere Forceps (420049)?

The FDA product code for Remanufactured EndoWrist Cadiere Forceps (420049) 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。

K250417翻新 EndoWrist Cobra 把手 (420190)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

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。