Amsel 結腸內閉堵器
K 號：K180650 · 2018-11-15
廣告
器材摘要
Amsel Endo Occluder is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical Corporation. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K180650. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Amsel Endo Occluder?
Amsel Endo Occluder is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Amsel Medical Corporation. The 510(k) number is K180650.
When did Amsel Endo Occluder receive FDA 510(k) clearance?
Amsel Endo Occluder received FDA 510(k) clearance on 2018-11-15, under 510(k) number K180650.
Who is the listed applicant for Amsel Endo Occluder?
The FDA 510(k) record lists Amsel Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Amsel Endo Occluder?
The FDA product code for Amsel Endo Occluder is FZP.
相關臨床試驗
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。
相關器械（代碼：FZP）
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。
K260677血管封閉設備（VCD177213P）Vcd Medical S.R.L.K254231Inno-Hook™ 一次性釘針應用器（結扎釘針）及 Inno-Hook™ 結扎釘針Taiwan Surgical CorporationK253781InnoClip 錄片應用器Taiwan Surgical CorporationK253903InnoClip 一次性夾子施用器Taiwan Surgical CorporationK250643一次性聚合物結合夾Hangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ 紫色加™ 大型聚合物結合夾Teleflex Medical
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。
廣告