FDA 510(k)

治療超級男性，治療超級女性，治療超級加強版

K 號：K221593 · 2022-11-17

決定日期2022-11-17

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K221593. 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 Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Convatec, Inc.. The 510(k) number is K221593.

When did Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus receive FDA 510(k) clearance?

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus received FDA 510(k) clearance on 2022-11-17, under 510(k) number K221593.

Who is the listed applicant for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

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

What is the FDA product code for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus?

The FDA product code for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus is EZD.

其他以 Convatec, Inc. 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。

K230400治療導管閉合系統；治療Dextra閉合系統

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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