免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Alcon 27GA Chandelier（8065000252）；Alcon 27+ DS广角内窥镜照明器（8065000253）；Alcon 27+ DS内窥镜照明器（8065000256）；

K号: K242184 · 2024-12-04

申请人Alcon Laboratories, Inc.
决定日期2024-12-04
产品代码MPA
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

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K242184. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);?

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K242184.

When did Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); receive FDA 510(k) clearance?

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242184.

Who is the listed applicant for Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);?

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

What is the FDA product code for Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);?

The FDA product code for Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); is MPA.

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 Laboratories, 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。

K254052DAILIES TOTAL1®; DAILIES TOTAL1® 多焦点K252682LenSx 激光系统（8065000944）K243896LenSx 激光系统（8065998162）K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal ToricK233876UNITY VCS（8065000296）；UNITY CS（8065000297）K233902Centurion®视觉系统（Active Sentry®）（8065753057）

查看所有 37 个设备 →

相关器械（代码：MPA）

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。

K253468诺瓦眼科 iTrack™ 250A 管道成形术微导管（iTrack™ 250A）Nova Eye, Inc.K233653中场光导纤维，23ga（3269.M06-00）；中场光导纤维，25ga（3269.M05-00）；中场光导纤维，27ga（3269.M04-00）Peregrine Surgical, LLCK221872ITrack高级通道成形术微导管及其高级输送系统Nova Eye Inc. (Business Name Nova Eye Medical)K202670Nam照明探头带斩波器Oculight , Ltd.

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。

↑