FDA 510(k)

EndoFLIP

K号: K160725 · 2016-05-01

决定日期2016-05-01

产品代码FFX

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决定实质等同

器械摘要

EndoFLIP is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2016-05-01 under 510(k) number K160725. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EndoFLIP?

EndoFLIP is a medical device that received FDA 510(k) clearance on 2016-05-01. The listed applicant is Crospon, Ltd.. The 510(k) number is K160725.

When did EndoFLIP receive FDA 510(k) clearance?

EndoFLIP received FDA 510(k) clearance on 2016-05-01, under 510(k) number K160725.

Who is the listed applicant for EndoFLIP?

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

What is the FDA product code for EndoFLIP?

The FDA product code for EndoFLIP is FFX.

列明Crospon, Ltd.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。

K183072EndoFLIP System K172128EsoFLIP® ES-310 Balloon Catheter K170833EndoFLIP® System with FLIP Topography module

官方来源

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