FDA 510(k)

VMCore活检针

K号: K201650 · 2021-01-15

决定日期2021-01-15

产品代码KNW

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决定实质等同

器械摘要

VMCore Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Uro-1, Inc.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201650. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VMCore Biopsy Needle?

VMCore Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Uro-1, Inc.. The 510(k) number is K201650.

When did VMCore Biopsy Needle receive FDA 510(k) clearance?

VMCore Biopsy Needle received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201650.

Who is the listed applicant for VMCore Biopsy Needle?

The FDA 510(k) record lists Uro-1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VMCore Biopsy Needle?

The FDA product code for VMCore Biopsy Needle is KNW.

列明Uro-1, 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：KNW）

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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