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FDA 510(k)

RENASYS Touch；RENASYS Y 连接器

K号: K181822 · 2019-03-21

申请人Smith & Nephew Medical Limited
决定日期2019-03-21
产品代码OMP
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

RENASYS Touch; RENASYS Y-Connector is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-03-21 under 510(k) number K181822. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RENASYS Touch; RENASYS Y-Connector?

RENASYS Touch; RENASYS Y-Connector is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181822.

When did RENASYS Touch; RENASYS Y-Connector receive FDA 510(k) clearance?

RENASYS Touch; RENASYS Y-Connector received FDA 510(k) clearance on 2019-03-21, under 510(k) number K181822.

Who is the listed applicant for RENASYS Touch; RENASYS Y-Connector?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS Touch; RENASYS Y-Connector?

The FDA product code for RENASYS Touch; RENASYS Y-Connector is OMP.

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Smith & Nephew Medical Limited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。

K242146BIOBRANE临时伤口敷料；BIOBRANE手套K223526ALLEVYN Ag+边缘抗菌硅胶凝胶复合水合泡沫敷料，ALLEVYN Ag+骶骨抗菌硅胶凝胶复合水合泡沫敷料，ALLEVYN Ag+手术抗菌硅胶凝胶复合水合泡沫敷料K220964VERSAJET 水刀手术系统（III）K213853RENASYS™-WF 白色泡沫 NPWT 敷料小号；RENASYS™-WF 白色泡沫 NPWT 敷料大号K223041Renasys Edge (66803126)K202783Renasys-F XL 泡沫敷料套装，带软端口，Renasys XL 透明薄膜敷料

查看所有 21 个设备 →

相关器械（代码：OMP）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 负压伤口治疗系统Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 罐 500-毫升 (CPC-500)Cork MedicalK254019伤口基因NPWT系统Bechtel Medical, Inc.

官方来源

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