FDA 510(k)

單次使用3 lumens針刀V型（KD-V441M，KD-V451M）

K 號：K252889 · 2025-11-25

決定日期2025-11-25

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252889. 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 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K252889.

When did Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) receive FDA 510(k) clearance?

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252889.

Who is the listed applicant for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

FDA 510(k) 記錄中將Olympus Medical Systems Corporation列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

The FDA product code for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is KNS.

其他以 Olympus Medical Systems Corporation 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。

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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.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 K251104SureTome™ SW 球尖電切刀Wilson-Cook Medical

官方來源

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