FDA 510(k)

Uroject12 注射器杠杆

K号: K180345 · 2018-10-17

决定日期2018-10-17

产品代码QBL

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Uroject12 Syringe Lever is the device name listed in this FDA 510(k) record. The listed applicant is Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2018-10-17 under 510(k) number K180345. The device is classified under product code QBL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Uroject12 Syringe Lever?

Uroject12 Syringe Lever is a medical device that received FDA 510(k) clearance on 2018-10-17. The listed applicant is Urogen Pharma, Ltd.. The 510(k) number is K180345.

When did Uroject12 Syringe Lever receive FDA 510(k) clearance?

Uroject12 Syringe Lever received FDA 510(k) clearance on 2018-10-17, under 510(k) number K180345.

Who is the listed applicant for Uroject12 Syringe Lever?

The FDA 510(k) record lists Urogen Pharma, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uroject12 Syringe Lever?

The FDA product code for Uroject12 Syringe Lever is QBL.

列明Urogen Pharma, 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。

K211032导尿管 12Fr，导尿管 16Fr K203321Cystoject注射器杠杆 K190987Uroject12 注射器杠杆 K180354UroGen 肾盂输尿管导管

官方来源

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