FDA 510(k)

Dragonfly® 胰胆镜；Dragonfly® 数字控制器；Dragonfly® 工具通道盖

K号: K233752 · 2024-05-02

决定日期2024-05-02

产品代码FBN

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决定实质等同

器械摘要

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is the device name listed in this FDA 510(k) record. The listed applicant is CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K233752. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is CenterPoint Systems, LLC. The 510(k) number is K233752.

When did Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps receive FDA 510(k) clearance?

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps received FDA 510(k) clearance on 2024-05-02, under 510(k) number K233752.

Who is the listed applicant for Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

FDA 510(k)记录中列出CenterPoint Systems, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

The FDA product code for Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is FBN.

列明CenterPoint Systems, LLC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。

K262240SSPC NXT 输送导管 K261766CPS 定位器 3D Plus 输送导管 K261492FieldFlex 可弯曲鞘 K260942AuST 可弯曲鞘 K260163AuST CSP 引导器 K250828CPS 定位器 3D Plus 输送导管

查看所有 15 个设备 →

相关器械（代码：FBN）

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。

K254153一次性视频内镜；PB数字控制器Mirco-Tech (Nanjing) Co., Ltd.K253139一次性远端帽Mirco-Tech (Nanjing) Co., Ltd.K251338胆管镜可视化系统（一次性视频胆管镜：SCV-P-01G，SCV-P-02G；全高清可视化内镜图像处理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）Scivita Medical Technology Co., Ltd.K251170Tangent 单次使用数字系统：Tangent 单次使用数字导管和 Tangent 数字控制器Tangent Endoscopy, LLC K243535柔性视频胆道镜（CHV-110J-U）；柔性视频胆道镜（CHV-US120J-U）Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444胆胰管内窥镜系统Shenzhen HugeMed Medical Technical Development Co., Ltd.

官方来源

在 FDA 数据库中查看 →

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