FDA 510(k)

Virtue 男用吊帶系統，附Alexis 切口拉開器便利套件

K 號：K231891 · 2023-09-25

決定日期2023-09-25

產品代碼OTM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定Unknown

器材摘要

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.

常見問題

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.

其他以 Coloplast 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241028Luja 女性用 (20051)；Luja 女性用 (20052)；Luja 女性用 (20054)；Luja 女性用 (20056)K230165盧雅曲 (20118 男 CH8 - 小型包裝（口袋尺寸）)、盧雅曲 (20111 男 CH10 - 小型包裝（口袋尺寸）)、盧雅曲 (20112 男 CH12 - 小型包裝（口袋尺寸）)、盧雅曲 (20114 男 CH14 - 小型包裝（口袋尺寸）)、盧雅曲 (20101 男 CH10 - 大型包裝)、盧雅曲 (20102 男 CH12 - 大型包裝)、盧雅曲 (20104 男 CH14 - 大型包裝)、盧雅曲 (20106 男 CH16 - 大型包裝)K223821自導尿閉環系統 K221401自導尿器及自導尿器加強版 K222059SpeediCath Flex Set K210250SpeedCath Compact 男性用

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相關器械（代碼：OTM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation K211847AdVance XP Male Sling SystemBoston Scientific Corporation K182169AdVance XP Male SlingBoston Scientific Corporation

官方來源

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