FDA 510(k)

Instylla输送套件

K号: K202544 · 2021-01-07

决定日期2021-01-07

产品代码FMF

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

Instylla Delivery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Instylla, Inc.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K202544. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Instylla Delivery Kit?

Instylla Delivery Kit is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Instylla, Inc.. The 510(k) number is K202544.

When did Instylla Delivery Kit receive FDA 510(k) clearance?

Instylla Delivery Kit received FDA 510(k) clearance on 2021-01-07, under 510(k) number K202544.

Who is the listed applicant for Instylla Delivery Kit?

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

What is the FDA product code for Instylla Delivery Kit?

The FDA product code for Instylla Delivery Kit is FMF.

列明Instylla, Inc.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。

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相关器械（代码：FMF）

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。

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官方来源

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