FDA 510(k)

AQUACEL Ag+ 加强型水凝胶敷料（含银和增强纤维）

K号: K173675 · 2018-07-20

决定日期2018-07-20

产品代码FRO

决定实质等同

器械摘要

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K173675. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber?

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Convatec Limited. The 510(k) number is K173675.

When did AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber receive FDA 510(k) clearance?

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber received FDA 510(k) clearance on 2018-07-20, under 510(k) number K173675.

Who is the listed applicant for AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber?

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 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber?

The FDA product code for AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber is FRO. This falls under the Anesthesiology category.

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 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

查看所有 10 个设备 →

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。