FDA 510(k)

GentleCath Air男性用；GentleCath Glide間歇性導尿管；GentleCath Air女性用

K 號：K252943 · 2026-04-01

決定日期2026-04-01

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K252943. 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 GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Convatec Limited. The 510(k) number is K252943.

When did GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women receive FDA 510(k) clearance?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women received FDA 510(k) clearance on 2026-04-01, under 510(k) number K252943.

Who is the listed applicant for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

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

What is the FDA product code for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

The FDA product code for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is EZD.

其他以 Convatec Limited 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。

K250891治療導管插入組（K1）；治療導管插入組（K2）；治療導管插入組（K2-90）；治療導管插入組（K3）；治療親水性導管組合包（HM12UK）；治療親水性導管組合包（HM14UK）；治療親水性導管組合包（HM16UK）；治療口袋導管組合包（M14UK）；治療導管閉合系統組合包（CS8）；治療導管閉合系統組合包（CS10）；治療導管閉合系統組合包（CS12）；治療導管閉合系統組合包（CS14）；治療導管閉合系統組合包（CS14C）K213283GentleCath Air 男性水性間歇性尿道導尿管 K190114Flexi-Seal PROTECT PLUS 粪便管理系統（含 ENFit 接頭）K180205AVELLE負壓創傷治療系統 K181206GentleCath Glide 间歇性尿道導尿管 K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

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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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