FDA 510(k)

Flexi-Seal PROTECT PLUS 粪便管理系统（带 ENFit 连接器）

K号: K190114 · 2019-04-30

决定日期2019-04-30

产品代码KNT

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190114. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Convatec Limited. The 510(k) number is K190114.

When did Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) receive FDA 510(k) clearance?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190114.

Who is the listed applicant for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

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 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

The FDA product code for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is KNT.

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）K213283GentleCath Air for Men 水性间歇性导尿管 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）

查看所有 10 个设备 →

相关器械（代码：KNT）

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。

K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)C.R. Bard, Inc.K250389XNY一次性胃腔校准管Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR（带 ENFit 连接器）Convatec K242336hygh-tec 排液IIAmb Medtec K242901ZZIREN™ 口胃管；ZZIREN™ SGT 口胃管 - 32 Fr（ZZ-SGT-32）；ZZIREN™ SGT 口胃管 - 36 Fr（ZZ-SGT-36）；ZZIREN™ SGT 口胃管 - 40 Fr（ZZ-SGT-40）；ZZIREN™ GBT 口胃管 - 32 Fr（ZZ-GBT-32）；ZZIREN™ GBT 口胃管 - 36 Fr（ZZ-GBT-36）；ZZIREN™ GBT 口胃管 - 40 Fr（ZZ-GBT-40）Tools For Surgery, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。