FDA 510(k)

One-Step 超耻骨引入器

K号: K182709 · 2018-12-26

决定日期2018-12-26

产品代码KOB

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决定实质等同

器械摘要

One-Step Suprapubic Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-12-26 under 510(k) number K182709. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the One-Step Suprapubic Introducer?

One-Step Suprapubic Introducer is a medical device that received FDA 510(k) clearance on 2018-12-26. The listed applicant is Cook Incorporated. The 510(k) number is K182709.

When did One-Step Suprapubic Introducer receive FDA 510(k) clearance?

One-Step Suprapubic Introducer received FDA 510(k) clearance on 2018-12-26, under 510(k) number K182709.

Who is the listed applicant for One-Step Suprapubic Introducer?

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

What is the FDA product code for One-Step Suprapubic Introducer?

The FDA product code for One-Step Suprapubic Introducer is KOB.

列明Cook Incorporated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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