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FDA 510(k)

SOLOASSIST IID / DEXTER内窥镜臂（212499）；ARTip solo（202426）+ ARTip solo语音（202445）；SOLOASSIST II（141364）+ 语音控制（171894）

K号: K233312 · 2024-08-08

申请人Aktormed GmbH
决定日期2024-08-08
产品代码QZB
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

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 is the device name listed in this FDA 510(k) record. The listed applicant is Aktormed GmbH. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233312. The device is classified under product code QZB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894?

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Aktormed GmbH. The 510(k) number is K233312.

When did SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 receive FDA 510(k) clearance?

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233312.

Who is the listed applicant for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894?

FDA 510(k)记录中列出Aktormed GmbH为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894?

The FDA product code for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 is QZB.

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

列明Aktormed GmbH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。

K261573内窥镜支架（182214）K232405ENDOFIX EXOK200473SoloAsisst II, 语音控制K171947SOLOASSIST II

相关器械（代码：QZB）

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。

K261573内窥镜支架（182214）Aktormed GmbHK250984Maestro系统（REF100）Moon SurgicalK242323Maestro系统（REF100）Moon Surgical

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。

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