FDA 510(k)

内窥镜注射针

K号: K240675 · 2024-10-04

申请人Promisemed Hangzhou Meditech Co., Ltd.

决定日期2024-10-04

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

Endoscopic Injection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K240675. 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 Endoscopic Injection Needles?

Endoscopic Injection Needles is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K240675.

When did Endoscopic Injection Needles receive FDA 510(k) clearance?

Endoscopic Injection Needles received FDA 510(k) clearance on 2024-10-04, under 510(k) number K240675.

Who is the listed applicant for Endoscopic Injection Needles?

FDA 510(k)记录将杭州普瑞美德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 Endoscopic Injection Needles?

The FDA product code for Endoscopic Injection Needles is FBK.

列明Promisemed Hangzhou Meditech 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。

K261719Promisemed X 安全笔式针头 K261196Promisemed VeriEcto 自动活检针 K261045Verifine 安全采血针 K254273Verisafe 安全无菌针（SSN）K250192Verisafe 安全可缩回胰岛素注射器 K250961血液采集管夹

查看所有 36 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

在 FDA 数据库中查看 →

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。