FDA 510(k)

AQUACEL Ag Surgical SP Dressing

K 號：K152926 · 2016-01-21

決定日期2016-01-21

產品代碼FRO

決定相當於

器材摘要

AQUACEL Ag Surgical SP Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K152926. 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.

常見問題

What is the AQUACEL Ag Surgical SP Dressing?

AQUACEL Ag Surgical SP Dressing is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Convatec Limited. The 510(k) number is K152926.

When did AQUACEL Ag Surgical SP Dressing receive FDA 510(k) clearance?

AQUACEL Ag Surgical SP Dressing received FDA 510(k) clearance on 2016-01-21, under 510(k) number K152926.

Who is the listed applicant for AQUACEL Ag Surgical SP Dressing?

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 Surgical SP Dressing?

The FDA product code for AQUACEL Ag Surgical SP Dressing is FRO. This falls under the Anesthesiology category.

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：FRO）

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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

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