FDA 510(k)

SureTome™ SW 球尖電切刀

K 號：K251104 · 2025-09-29

決定日期2025-09-29

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

SureTome™ SW Sphincterotome with DomeTip is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K251104. 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 SureTome™ SW Sphincterotome with DomeTip?

SureTome™ SW Sphincterotome with DomeTip is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Wilson-Cook Medical. The 510(k) number is K251104.

When did SureTome™ SW Sphincterotome with DomeTip receive FDA 510(k) clearance?

SureTome™ SW Sphincterotome with DomeTip received FDA 510(k) clearance on 2025-09-29, under 510(k) number K251104.

Who is the listed applicant for SureTome™ SW Sphincterotome with DomeTip?

The FDA 510(k) record lists Wilson-Cook Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureTome™ SW Sphincterotome with DomeTip?

The FDA product code for SureTome™ SW Sphincterotome with DomeTip is KNS.

其他以 Wilson-Cook Medical 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。

K213483SnapLoc 電纜鎖

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

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。