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FDA 510(k)

HyperVit玻璃体切除探针，23 GA，HyperVit玻璃体切除探针，25+，HyperVit玻璃体切除探针，27+

K号: K170520 · 2017-03-22

申请人Alcon Research, Ltd.
决定日期2017-03-22
产品代码MLZ
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

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K170520. The device is classified under product code MLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K170520.

When did HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ receive FDA 510(k) clearance?

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ received FDA 510(k) clearance on 2017-03-22, under 510(k) number K170520.

Who is the listed applicant for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

The FDA 510(k) record lists Alcon Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

The FDA product code for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is MLZ.

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Alcon Research, Ltd.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。

K161794CENTURION Vision系统（Active SentryTM）

相关器械（代码：MLZ）

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。

K220030维斯塔眼科玻璃体切除探头Vista Ophthalmics, LLC

官方来源

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