FDA 510(k)

富士通熱絲切刀（FlushKnife），熱絲切刀（ClutchCutter）

K 號：K151474 · 2016-02-18

決定日期2016-02-18

產品代碼KGE

諮詢委員會GU

決定相當於

器材摘要

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K151474. 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 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)?

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K151474.

When did Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) receive FDA 510(k) clearance?

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151474.

Who is the listed applicant for Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)?

The FDA product code for Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) is KGE.

其他以 Fujifilm Medical System U.S.A., Inc. 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。

K163675處理器 VP-7000，光源 BL-7000 K153206富士通超音波處理器 SU-1 PLATINUM 及 SU-1

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 Corporation K242857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 Corporation K210406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。