ProGrip™ 自粘聚丙烯网眼布
K号: K243315 · 2025-01-17
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决定日期2025-01-17
产品代码FTL
咨询委员会SU
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决定实质等同
器械摘要
ProGrip™ Self-Gripping Polypropylene Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243315. 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 ProGrip™ Self-Gripping Polypropylene Mesh?
ProGrip™ Self-Gripping Polypropylene Mesh is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Sofradim Production. The 510(k) number is K243315.
When did ProGrip™ Self-Gripping Polypropylene Mesh receive FDA 510(k) clearance?
ProGrip™ Self-Gripping Polypropylene Mesh received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243315.
Who is the listed applicant for ProGrip™ Self-Gripping Polypropylene Mesh?
The FDA 510(k) record lists Sofradim Production as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProGrip™ Self-Gripping Polypropylene Mesh?
The FDA product code for ProGrip™ Self-Gripping Polypropylene 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Sofradim Production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 ProductionK251955Onflex® 网格Davol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® 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.
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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