FDA 510(k)

GentleCath Air 男性水性間歇性尿道導尿管

K 號：K213283 · 2022-06-22

決定日期2022-06-22

產品代碼GBM

諮詢委員會GU

決定相當於

器材摘要

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K213283. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Convatec Limited. The 510(k) number is K213283.

When did GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter receive FDA 510(k) clearance?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter received FDA 510(k) clearance on 2022-06-22, under 510(k) number K213283.

Who is the listed applicant for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

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 Hydrophilic Intermittent Urinary Catheter?

The FDA product code for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is GBM.

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。

K252943GentleCath Air男性用；GentleCath Glide間歇性導尿管；GentleCath Air女性用 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）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：GBM）

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。

K241734Wellead® 水性間歇性導尿管預先使用型；Wellead® 水性間歇性導尿管簡易型Well Lead Medical Co., Ltd.K211436間斷導尿管（未定案）Hollister Incorporated K200820SpeediCath 簡易設備組Coloplast K192904SpeediCath 簡易設備組Coloplast K200142SpeediCath 軟體Coloplast K200134吉木士一次性无菌尿道導尿管Hangzhou Jimushi Meditech Co., Ltd.

官方來源

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