FDA 510(k)

單次使用括約肌斷刀V型（遠端導絲引導）KD-VC412Q-0215

K 號：K160241 · 2016-03-02

決定日期2016-03-02

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K160241. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K160241.

When did Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 receive FDA 510(k) clearance?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 received FDA 510(k) clearance on 2016-03-02, under 510(k) number K160241.

Who is the listed applicant for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

FDA 510(k) 記錄將Olympus Medical Systems Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

The FDA product code for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is KNS.

其他以 Olympus Medical Systems Corp. 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。

K2620794K攝影鏡頭 OLYMPUS CH-S700-08-LB 医療設備規範文本 K254056THUNDERBEAT 5 mm, 45 cm, 前動握把型 S (TB-0545FCS)；THUNDERBEAT 5 mm, 35 cm, 前動握把型 S (TB-0535FCS)；THUNDERBEAT 5 mm, 20 cm, 前動握把型 S (TB-0520FCS)K260580單次使用可重裝夾釘應用器（HX-810LR，HX-810UR）；夾釘（HX-610-090，HX-610-135）；長夾釘（HX-610-090L，HX-610-135L）；短夾釘（HX-610-090S，HX-610-135S）；超短夾釘（HX-610-135XS）K252341EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-Q190)；EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-H190)；EVIS EXERA III 支气管內視鏡 (OLYMPUS BF-1TH190)K251807單次使用電外科止血鉗 FD-410LR, FD-411UR, FD-412LR K253646單次使用遠端蓋 MAJ-2315 (MAJ-2315)

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相關器械（代碼：KNS）

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。

K262460Rezum系統Boston Scientific K260962括約肌切除器Taewoong Medical Co., Ltd.K252388征服水蒸氣消融設備Francis Medical, Inc.K252889單次使用3 lumens針刀V型（KD-V441M，KD-V451M）Olympus Medical Systems Corporation K250945單次使用預裝式括約肌斷刀V型（遠端導絲導引）(KD-VC600系列)；單次使用括約肌斷刀V型（遠端導絲導引）(KD-VC400系列)；單次使用3腔括約肌斷刀(KD-V系列)；一次性三腔括約肌斷刀(KD系列)Olympus Medical Systems Corp.K250351單次使用電外科刀（KD-612L，KD-612U）；單次使用電外科刀（KD-620UR）；單次使用電外科刀（KD-650L，KD-650U）Olympus Medical Systems Corporation

官方來源

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