FDA 510(k)

美德男性吊带系统及艾利克斯伤口拉钩便捷套装

K号: K231891 · 2023-09-25

决定日期2023-09-25

产品代码OTM

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决定Unknown

器械摘要

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231891. The device is classified under product code OTM. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

常见问题

What is the Virtue Male Sling System with Alexis Wound Retractor Convenience Kit?

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Coloplast. The 510(k) number is K231891.

When did Virtue Male Sling System with Alexis Wound Retractor Convenience Kit receive FDA 510(k) clearance?

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231891.

Who is the listed applicant for Virtue Male Sling System with Alexis Wound Retractor Convenience Kit?

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

What is the FDA product code for Virtue Male Sling System with Alexis Wound Retractor Convenience Kit?

The FDA product code for Virtue Male Sling System with Alexis Wound Retractor Convenience Kit is OTM.

列明Coloplast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。

K241028Luja女性（20051）；Luja女性（20052）；Luja女性（20054）；Luja女性（20056）K230165Luja 弯头（20118 男 CH8 - 小包装（口袋大小）），Luja 弯头（20111 男 CH10 - 小包装（口袋大小）），Luja 弯头（20112 男 CH12 - 小包装（口袋大小）），Luja 弯头（20114 男 CH14 - 小包装（口袋大小）），Luja 弯头 (20101 男 CH10 - 大包装)，Luja 弯头 (20102 男 CH12 - 大包装)，Luja 弯头 (20104 男 CH14 - 大包装)，Luja 弯头 (20106 男 CH16 - 大包装)K223821自用闭式导尿系统 K221401自用闭式导尿系统及自用闭式导尿系统+K222059SpeediCath Flex 套件 K210250SpeedCath 紧凑型男性

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。