FDA 510(k)

Perineologic Access Needle

K号: K160423 · 2016-09-02

决定日期2016-09-02

产品代码FCG

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决定实质等同

器械摘要

Perineologic Access Needle is the device name listed in this FDA 510(k) record. The listed applicant is Corbin Clinical Resources, LLC. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K160423. 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 Perineologic Access Needle?

Perineologic Access Needle is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Corbin Clinical Resources, LLC. The 510(k) number is K160423.

When did Perineologic Access Needle receive FDA 510(k) clearance?

Perineologic Access Needle received FDA 510(k) clearance on 2016-09-02, under 510(k) number K160423.

Who is the listed applicant for Perineologic Access Needle?

The FDA 510(k) record lists Corbin Clinical Resources, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perineologic Access Needle?

The FDA product code for Perineologic Access Needle is FCG.

列明Corbin Clinical Resources, LLC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。

K160414Precision Point Biopsy Needle Guide

官方来源

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