FDA 510(k)

EchoTip® AcuCore™ 超聲波針吸針 (ECHO-BX-3-22)

K 號：K230909 · 2023-05-30

決定日期2023-05-30

產品代碼FCG

諮詢委員會GU

決定相當於

器材摘要

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K230909. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K230909.

When did EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) receive FDA 510(k) clearance?

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) received FDA 510(k) clearance on 2023-05-30, under 510(k) number K230909.

Who is the listed applicant for EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

FDA 510(k) 記錄將 Cook Ireland, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

The FDA product code for EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is FCG.

其他以 Cook Ireland, Ltd. 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。

K261274EchoTip Ultra® 高解析度內視鏡超聲針對 Fujifilm 鏡頭；EchoTip ProCore® 高解析度內視鏡超聲針對 Fujifilm 鏡頭 K241209EchoTip AcuCore™ EUS 結締針 (ECHO-BX-19)K233079Zimmon® 胰腺支架/支架組（SPSOF、SPSOS、ZEPDF、ZEPDS、ZPSOF、ZPSOS）；Geenen® 胰腺支架/支架組（GEPD、GPDS、GPSO、GPSOS）；Johlin® 胰腺楔形支架及導入組（JPWS）；推入式導管及導引式導管（GC、PC）；Geenen® Sof-Flex® 胰腺支架（GPSO-SF、GPSOS-SF）K213946Compass BDS 胆道支架 K210476EchoTip Ultra內視鏡超聲針，EchoTip ProCore HD超聲針吸組織切片，EchoTip Ultra內支氣管高解析度超聲針，EchoTip ProCore內支氣管高解析度超聲針吸組織切片 K182980Zilver 518 胆管支架，Zilver 635 胆管支架

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相關器械（代碼：FCG）

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。

K252646單次使用細針穿刺活檢（FNB）設備（NA-U210H）Olympus Medical Systems Corp.K250994ClearTip FNA及FNB型別Finemedix Co., Ltd.K241209EchoTip AcuCore™ EUS 結締針 (ECHO-BX-19)Cook Ireland, Ltd.K231422精準胃腸內科設備Limaca Medical, Ltd.K231267清針Finemedix Co., Ltd.K212423EndoDrill® 型號 XBibbinstruments AB

官方來源

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