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FDA 510(k)

机器人手术器械 - 永久电灼钩（470183）；机器人手术器械 - 永久电灼铲（470184）

K号: K252926 · 2026-03-26

申请人Restore Robotics
决定日期2026-03-26
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

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) is the device name listed in this FDA 510(k) record. The listed applicant is Restore Robotics. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K252926. 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 Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Restore Robotics. The 510(k) number is K252926.

When did Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) receive FDA 510(k) clearance?

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K252926.

Who is the listed applicant for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

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

What is the FDA product code for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

The FDA product code for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K250417翻新 EndoWrist Cobra 把手 (420190)RebotixK250399翻新 EndoWrist Cadiere 力爪 (420049)RebotixK250387翻新 EndoWrist 长尖力爪 (420048)RebotixK250539翻新 EndoWrist 十字钳力爪 (420207)RebotixK2426108mm单极弯曲剪刀（470179）Iconocare HealthK241872翻新 EndoWrist ProGrasp 力爪 (420093)Rebotix

官方来源

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