FDA 510(k)

Biopsy Needle

K号: K191472 · 2020-01-29

决定日期2020-01-29

产品代码FCG

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决定实质等同

器械摘要

Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ushare Medical, Inc.. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K191472. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biopsy Needle?

Biopsy Needle is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Ushare Medical, Inc.. The 510(k) number is K191472.

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

Biopsy Needle received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191472.

Who is the listed applicant for Biopsy Needle?

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

What is the FDA product code for Biopsy Needle?

The FDA product code for Biopsy Needle is FCG.

列明Ushare Medical, 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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官方来源

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