PREVENA RESTOR(TM) 切口管理系统
K号: K181507 · 2019-02-15
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器械摘要
PREVENA RESTOR(TM) Incision Management System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K181507. 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 PREVENA RESTOR(TM) Incision Management System?
PREVENA RESTOR(TM) Incision Management System is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Kci USA, Inc.. The 510(k) number is K181507.
When did PREVENA RESTOR(TM) Incision Management System receive FDA 510(k) clearance?
PREVENA RESTOR(TM) Incision Management System received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181507.
Who is the listed applicant for PREVENA RESTOR(TM) Incision Management System?
The FDA 510(k) record lists Kci USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PREVENA RESTOR(TM) Incision Management System?
The FDA product code for PREVENA RESTOR(TM) Incision Management System 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。
列明Kci USA, 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。
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
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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