恩西茲爾單極內視鏡剪
K 號：K180134 · 2018-06-29
廣告
器材摘要
Ensizor Monopolar Endoscopic Scissors is the device name listed in this FDA 510(k) record. The listed applicant is Slater Endoscopy, LLC. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180134. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ensizor Monopolar Endoscopic Scissors?
Ensizor Monopolar Endoscopic Scissors is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Slater Endoscopy, LLC. The 510(k) number is K180134.
When did Ensizor Monopolar Endoscopic Scissors receive FDA 510(k) clearance?
Ensizor Monopolar Endoscopic Scissors received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180134.
Who is the listed applicant for Ensizor Monopolar Endoscopic Scissors?
The FDA 510(k) record lists Slater Endoscopy, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ensizor Monopolar Endoscopic Scissors?
The FDA product code for Ensizor Monopolar Endoscopic Scissors is KGE.
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：KGE）
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。
K251807單次使用電外科止血鉗 FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187一次性熱式組織切片镊子（FD-210U）；一次性熱式組織切片镊子（FD-230U）Olympus Medical Systems CorporationK242857清晰血漿吸取器Finemedix Co., Ltd.K231721一次性熱式組織切除镊Beijing Zksk Technology Co., Ltd.K220053電熱切刀（平刀）DK2620JI 及 DK2623JIFujifilm CorporationK210406雙極凝固鉗Hangzhou AGS MedTech Co., Ltd.
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