FDA 510(k)

GentleCath Air for Men 水性间歇性导尿管

K号: K213283 · 2022-06-22

决定日期2022-06-22

产品代码GBM

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决定实质等同

器械摘要

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.

常见问题

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.

列明Convatec Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252943GentleCath Air for Men; GentleCath Glide 间歇性导尿管; GentleCath Air for Women K250891Cure 管道插入套装（K1）；Cure 管道插入套装（K2）；Cure 管道插入套装（K2-90）；Cure 管道插入套装（K3）；Cure 润滑性导管套装（HM12UK）；Cure 润滑性导管套装（HM14UK）；Cure 润滑性导管套装（HM16UK）；Cure 口袋导管套装（M14UK）；Cure 管道闭合系统套装（CS8）；Cure 管道闭合系统套装（CS10）；Cure 管道闭合系统套装（CS12）；Cure 管道闭合系统套装（CS14）；Cure 管道闭合系统套装（CS14C）K190114Flexi-Seal PROTECT PLUS 粪便管理系统（带 ENFit 连接器）K180205AVELLE 负压伤口治疗系统 K181206GentleCath Glide 间歇性导尿管 K173675AQUACEL Ag+ 加强型水凝胶敷料（含银和增强纤维）

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官方来源

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