FDA 510(k)

自導尿器及自導尿器加強版

K 號：K221401 · 2022-12-02

決定日期2022-12-02

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

Self-Cath and Self-Cath Plus is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221401. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Self-Cath and Self-Cath Plus?

Self-Cath and Self-Cath Plus is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Coloplast. The 510(k) number is K221401.

When did Self-Cath and Self-Cath Plus receive FDA 510(k) clearance?

Self-Cath and Self-Cath Plus received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221401.

Who is the listed applicant for Self-Cath and Self-Cath Plus?

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 Self-Cath and Self-Cath Plus?

The FDA product code for Self-Cath and Self-Cath Plus is EZD.

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)K231891Virtue 男用吊帶系統，附Alexis 切口拉開器便利套件 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 K222059SpeediCath Flex Set K210250SpeedCath Compact 男性用

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相關器械（代碼：EZD）

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。

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ 即用型親水性間歇性導尿管女性用 (CH06 - CH16)；Cure Aqua™ 即用型親水性間歇性導尿管男性直型 (CH06 - CH18)；Cure Aqua™ 即用型親水性間歇性導尿管男性彎型 (CH10 - CH18)。Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045盧加軟件Coloplast A.S.K260394親水性塗層單次使用間歇性奈頓導尿管（NCR）Hangzhou Jimushi Meditech Co., Ltd.K253295曲管套筒內芯IC；曲管加套筒內芯ICHollister Incorporated

官方來源

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