FDA 510(k)

Progrip® 自锁聚丙烯网

K号: K232373 · 2024-01-18

决定日期2024-01-18

产品代码FTL

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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 2024-01-18 under 510(k) number K232373. 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 2024-01-18. The listed applicant is Sofradim Production. The 510(k) number is K232373.

When did Progrip™ Self-Gripping Polypropylene Mesh receive FDA 510(k) clearance?

Progrip™ Self-Gripping Polypropylene Mesh received FDA 510(k) clearance on 2024-01-18, under 510(k) number K232373.

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.

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。

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官方来源

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