FDA 510(k)

EchoTip® AcuCore™ 超声活检针 (ECHO-BX-3-22)

K号: K230909 · 2023-05-30

决定日期2023-05-30

产品代码FCG

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决定实质等同

器械摘要

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.

常见问题

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)记录中列出Cook Ireland, Ltd.为申请人。这本身并不能确立该设备的制造商。

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.

列明Cook Ireland, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261274EchoTip Ultra® 内镜超声活检针，适用于富士胶片内窥镜；EchoTip ProCore® 内镜超声活检针，适用于富士胶片内窥镜 K241209EchoTip AcuCore™ EUS 细胞活检针 (ECHO-BX-19)K233079Zimmon® 胰腺支架/支架套装（SPSOF，SPSOS，ZEPDF，ZEPDS，ZPSOF，ZPSOS）；Geenen® 胰腺支架/支架套装（GEPD，GPDS，GPSO，GPSOS）；Johlin® 胰腺楔形支架和导引器套装（JPWS）；推送导管和导引导管（GC，PC）；Geenen® Sof-Flex® 胰腺支架（GPSO-SF，GPSOS-SF）K213946Compass BDS 胆管支架 K210476EchoTip Ultra 内镜超声针，EchoTip ProCore HD 超声活检针，EchoTip Ultra 内镜支气管高清晰度超声针，EchoTip ProCore 内镜支气管高清晰度活检针 K182980Zilver 518 胆管支架，Zilver 635 胆管支架

查看所有 16 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。