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FDA 510(k)

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)

K 號：K250945 · 2025-10-17

申請人Olympus Medical Systems Corp.
決定日期2025-10-17
產品代碼KNS
諮詢委員會GU
決定相當於

器材摘要

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) 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 2025-10-17 under 510(k) number K250945. 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 Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)?

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K250945.

When did Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) receive FDA 510(k) clearance?

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250945.

Who is the listed applicant for Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)?

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 Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)?

The FDA product code for Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) is KNS.

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。

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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-412LRK253646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 ScientificK260962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 CorporationK250351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 CorporationK251104SureTome™ SW 球尖電切刀Wilson-Cook Medical

官方來源

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