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FDA 510(k)

涡流手术激光探头，涡流手术照明激光探头，涡流手术内窥镜照明器，涡流手术吊灯

K号: K220263 · 2022-11-03

申请人Vortex Surgical, Inc.
决定日期2022-11-03
产品代码HQB
咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is the device name listed in this FDA 510(k) record. The listed applicant is Vortex Surgical, Inc.. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K220263. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Vortex Surgical, Inc.. The 510(k) number is K220263.

When did Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers receive FDA 510(k) clearance?

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers received FDA 510(k) clearance on 2022-11-03, under 510(k) number K220263.

Who is the listed applicant for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

The FDA 510(k) record lists Vortex Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers?

The FDA product code for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers is HQB.

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Vortex Surgical, Inc.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。

K191846MAXReach 激光探头

相关器械（代码：HQB）

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。

K191846MAXReach 激光探头Vortex Surgical, Inc.K182646Vitreq一次性激光探头、光纤和烛台VitreQ BV

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。

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