FDA 510(k)

硬化疗法针

K号: K212668 · 2022-02-23

申请人Zhejiang Chuangxiang Medical Technology Co., Ltd.

决定日期2022-02-23

产品代码FBK

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Sclerotherapy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212668. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sclerotherapy Needle?

Sclerotherapy Needle is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K212668.

When did Sclerotherapy Needle receive FDA 510(k) clearance?

Sclerotherapy Needle received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212668.

Who is the listed applicant for Sclerotherapy Needle?

FDA 510(k)记录将浙江创想医疗科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Sclerotherapy Needle?

The FDA product code for Sclerotherapy Needle is FBK.

列明Zhejiang Chuangxiang Medical Technology Co., 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。

K260410单次使用输尿管通道鞘 K253132一次性结石取出球囊 K251890一次性输尿管支架 K230773内镜冲洗管 K231471空气/水瓶软管，CO2 源软管 K220063一次性细胞刷

查看所有 14 个设备 →

相关器械（代码：FBK）

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。

官方来源

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