Onflex® 网格
K号: K251955 · 2025-07-24
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决定日期2025-07-24
产品代码FTL
咨询委员会SU
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器械摘要
Onflex™ Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K251955. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Onflex™ Mesh?
Onflex™ Mesh is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. The 510(k) number is K251955.
When did Onflex™ Mesh receive FDA 510(k) clearance?
Onflex™ Mesh received FDA 510(k) clearance on 2025-07-24, under 510(k) number K251955.
Who is the listed applicant for Onflex™ Mesh?
The FDA 510(k) record lists Davol Inc., Subsidiary of C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Onflex™ Mesh?
The FDA product code for Onflex™ Mesh is FTL.
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Davol Inc., Subsidiary of C. R. Bard, 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：FTL）
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。
K253956ProGrip™ 高级自粘聚丙烯网眼布 (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene® 平面网网格Medtronic - Sofradim ProductionK251557Bard® 网状物；Bard® 网状物预成型Davol, Inc.K250869Parietene® Macroporous 网格 (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh 预成型Davol, Inc.K243315ProGrip™ 自粘聚丙烯网眼布Sofradim Production
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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