FDA 510(k)

ProGrip™ 高级自粘聚丙烯网眼布 (ADG1510, ADG2015, ADG3020, ADG4030)

K号: K253956 · 2026-05-21

决定日期2026-05-21

产品代码FTL

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决定实质等同

器械摘要

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K253956. 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™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Sofradim Production. The 510(k) number is K253956.

When did ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) receive FDA 510(k) clearance?

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253956.

Who is the listed applicant for ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

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™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

The FDA product code for ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) is FTL.

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。

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 K220586Symbotex 复合网片，ProGrip 自握聚酯网片，Parietex 水性 2D 3D 解剖网片，Versatex 单丝网片

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官方来源

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