FDA 510(k)

SmartClip 輸送導管 (ADR-1715)

K 號：K260565 · 2026-05-14

決定日期2026-05-14

產品代碼EOQ

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

SmartClip Delivery Catheter (ADR-1715) is the device name listed in this FDA 510(k) record. The listed applicant is Elucent Medical. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260565. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartClip Delivery Catheter (ADR-1715)?

SmartClip Delivery Catheter (ADR-1715) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Elucent Medical. The 510(k) number is K260565.

When did SmartClip Delivery Catheter (ADR-1715) receive FDA 510(k) clearance?

SmartClip Delivery Catheter (ADR-1715) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260565.

Who is the listed applicant for SmartClip Delivery Catheter (ADR-1715)?

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

What is the FDA product code for SmartClip Delivery Catheter (ADR-1715)?

The FDA product code for SmartClip Delivery Catheter (ADR-1715) is EOQ.

相關器械（代碼：EOQ）

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。

K261637單次使用柔軟式支氣管內鏡Hunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 銀喉鏡 2.7/1.2；Ambu® aScope™ 5 銀喉鏡 4.2/2.2；Ambu® aScope™ 5 銀喉鏡 4.2/2.2 樣本組Ambu A/S K2540263.8mm 瘦版 ProVu 電子內視鏡 (090-02-0038U)；5.0mm 标準 ProVu 電子內視鏡 (090-02-0050U)；6.0mm 大型 ProVu 電子內視鏡 (090-02-0060U)；ProVu 電子內視鏡 8 識別器 (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ 平台（MON-000008）Auris Health, Inc.K254037肺流氣道導管Free Flow Medical, Inc.K253137富士通內視鏡型號 EB-840S；富士通內視鏡型號 EB-840TFujifilm Corporation

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：EOQ）

官方來源