FDA 510(k)

Instinct Plus Endoscopic Clipping Device

K号: K212323 · 2021-08-25

决定日期2021-08-25

产品代码PKL

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决定实质等同

器械摘要

Instinct Plus Endoscopic Clipping Device is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K212323. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Instinct Plus Endoscopic Clipping Device?

Instinct Plus Endoscopic Clipping Device is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K212323.

When did Instinct Plus Endoscopic Clipping Device receive FDA 510(k) clearance?

Instinct Plus Endoscopic Clipping Device received FDA 510(k) clearance on 2021-08-25, under 510(k) number K212323.

Who is the listed applicant for Instinct Plus Endoscopic Clipping Device?

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

What is the FDA product code for Instinct Plus Endoscopic Clipping Device?

The FDA product code for Instinct Plus Endoscopic Clipping Device is PKL.

列明Wilson-Cook 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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相关器械（代码：PKL）

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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