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FDA 510(k)

Parietex 手术网（修改为 Parietex Hydrophilic 2D、3D、解剖网），Parietex 复合网（PCO 和 PCO-OS 参考），Parietex 优化复合网（PCO-X、PCO-FX 和 PCO-OSX 参考）

K号: K173796 · 2018-03-09

申请人Sofradim Production
决定日期2018-03-09
产品代码FTL
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

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2018-03-09 under 510(k) number K173796. 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 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)?

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Sofradim Production. The 510(k) number is K173796.

When did Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) receive FDA 510(k) clearance?

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173796.

Who is the listed applicant for Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)?

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 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)?

The FDA product code for Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) 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。

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。

K253956ProGrip™ 高级自粘聚丙烯网眼布 (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene® Macroporous 网格 (PPM5050 )K243315ProGrip™ 自粘聚丙烯网眼布K233661Transorb™ 自粘性可吸收网K232373Progrip® 自锁聚丙烯网K223218Parietene Macroporous 网格

查看所有 11 个设备 →

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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