FDA 510(k)

GentleCath Glide 间歇性導尿管

K 號：K161344 · 2016-09-20

決定日期2016-09-20

產品代碼KOD

諮詢委員會GU

決定相當於

器材摘要

GentleCath Glide Intermittent 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 2016-09-20 under 510(k) number K161344. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GentleCath Glide Intermittent Catheter?

GentleCath Glide Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Convatec Limited. The 510(k) number is K161344.

When did GentleCath Glide Intermittent Catheter receive FDA 510(k) clearance?

GentleCath Glide Intermittent Catheter received FDA 510(k) clearance on 2016-09-20, under 510(k) number K161344.

Who is the listed applicant for GentleCath Glide Intermittent 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 Glide Intermittent Catheter?

The FDA product code for GentleCath Glide Intermittent Catheter is KOD.

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）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

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相關器械（代碼：KOD）

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。

K251864橡膠多功能導尿管C.R. Bard, Inc.K220036Wellead 腎管導尿管Well Lead Medical Co., Ltd.K220730allFlex 腎管導管，Krait 腎管導管Allwin Medical Devices, Inc.K211032尿道導尿管 12 Fr，尿道導尿管 16 FrUrogen Pharma, Ltd.K181979魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管Teleflexmedical, Inc.K180354UroGen 腎盂導尿管Urogen Pharma, Ltd.

官方來源

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