FDA 510(k)

Flexi-Seal PROTECT PLUS 粪便管理系統（含 ENFit 接頭）

K 號：K190114 · 2019-04-30

決定日期2019-04-30

產品代碼KNT

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

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 K180205AVELLE負壓創傷治療系統 K181206GentleCath Glide 间歇性尿道導尿管 K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

查看所有 10 項裝置 →

相關器械（代碼：KNT）

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。

K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514明尼蘇達四腔道食道-胃填塞管 - 18法蘭 (0092220)；Blakemore 食道-鼻胃管 - 20法蘭 (0092100)；Blakemore 食道-鼻胃管 - 16法蘭 (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（配ENFit連接器）Convatec K242336hygh-tec 排水IIAmb Medtec K242901ZZIREN™ 適胃管；ZZIREN™ SGT 適胃管 - 32 Fr (ZZ-SGT-32)；ZZIREN™ SGT 適胃管 - 36 Fr (ZZ-SGT-36)；ZZIREN™ SGT 適胃管 - 40 Fr (ZZ-SGT-40)；ZZIREN™ GBT 適胃管 - 32 Fr (ZZ-GBT-32)；ZZIREN™ GBT 適胃管 - 36 Fr (ZZ-GBT-36)；ZZIREN™ GBT 適胃管 - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。