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FDA 510(k)

BeneHold® 手术切口巾,含CHG抗菌剂 II

K号: K230645 · 2023-10-25

决定日期2023-10-25
产品代码KKX
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

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Medical , Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230645. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Avery Dennison Medical , Ltd.. The 510(k) number is K230645.

When did BeneHold™ Surgical Incise Drape with CHG antimicrobial II receive FDA 510(k) clearance?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230645.

Who is the listed applicant for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA 510(k) record lists Avery Dennison Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II is KKX.

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。

相关器械(代码:KKX)

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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