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FDA 510(k)

Bard Soft Mesh; Bard Soft Mesh 预成型

K号: K250098 · 2025-04-09

申请人Davol, Inc.
决定日期2025-04-09
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

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K250098. 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 Bard Soft Mesh; Bard Soft Mesh Pre-Shaped?

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Davol, Inc.. The 510(k) number is K250098.

When did Bard Soft Mesh; Bard Soft Mesh Pre-Shaped receive FDA 510(k) clearance?

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped received FDA 510(k) clearance on 2025-04-09, under 510(k) number K250098.

Who is the listed applicant for Bard Soft Mesh; Bard Soft Mesh Pre-Shaped?

The FDA 510(k) record lists Davol, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bard Soft Mesh; Bard Soft Mesh Pre-Shaped?

The FDA product code for Bard Soft Mesh; Bard Soft Mesh Pre-Shaped 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.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。

官方来源

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