FDA 510(k)

ANDORATE® 吸引阀和ANDORATE® 活检阀

K号: K230280 · 2023-05-11

决定日期2023-05-11

产品代码KTI

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决定实质等同

器械摘要

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K230280. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Ga Health Company Limited. The 510(k) number is K230280.

When did ANDORATE® Suction Valve and ANDORATE® Biopsy Valve receive FDA 510(k) clearance?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve received FDA 510(k) clearance on 2023-05-11, under 510(k) number K230280.

Who is the listed applicant for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

The FDA product code for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is KTI.

列明Ga Health Company Limited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。

K232118ANDORATE® 阀门套件 K231602Protego 空气水连接器；Protego 空气水瓶管；Protego 混合管 K230932ANDORATE® 阀门套件 K223171AquaPulse® 灌洗软管 K213095安道瑞吸阀，安道瑞气/水阀 K202838Andorate Universal Endoscope Tip Guard

查看所有 12 个设备 →

相关器械（代码：KTI）

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Cook Ireland, Ltd.K251478ClearTip TBNA 类型Finemedix Co., Ltd.K254040LungFlow篮状导管Free Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass可调针，配备适配器SRA-1-01和SRA-2-01Serpex Medical, Inc.K251664一次性吸引针（NA-201SX-4021）；一次性吸引针（NA-201SX-4022）Olympus Medical Systems Corporation

官方来源

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