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FDA 510(k)

Tegaderm 术后透明抗菌敷料

K号: K251866 · 2025-10-10

决定日期2025-10-10
产品代码FRO
决定实质等同

器械摘要

Tegaderm Post-Op Transparent Antimicrobial Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Solventum US, LLC. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K251866. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Tegaderm Post-Op Transparent Antimicrobial Dressing?

Tegaderm Post-Op Transparent Antimicrobial Dressing is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Solventum US, LLC. The 510(k) number is K251866.

When did Tegaderm Post-Op Transparent Antimicrobial Dressing receive FDA 510(k) clearance?

Tegaderm Post-Op Transparent Antimicrobial Dressing received FDA 510(k) clearance on 2025-10-10, under 510(k) number K251866.

Who is the listed applicant for Tegaderm Post-Op Transparent Antimicrobial Dressing?

FDA 510(k)记录中列出Solventum US, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Tegaderm Post-Op Transparent Antimicrobial Dressing?

The FDA product code for Tegaderm Post-Op Transparent Antimicrobial Dressing is FRO. This falls under the Anesthesiology category.

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Solventum US, LLC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:FRO)

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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