FDA 510(k)

EverLift黏膜提升剂

K号: K202376 · 2020-09-30

决定日期2020-09-30

产品代码PLL

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决定实质等同

器械摘要

EverLift Submucosal Lifting Agent is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply, Inc.. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K202376. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EverLift Submucosal Lifting Agent?

EverLift Submucosal Lifting Agent is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is Gi Supply, Inc.. The 510(k) number is K202376.

When did EverLift Submucosal Lifting Agent receive FDA 510(k) clearance?

EverLift Submucosal Lifting Agent received FDA 510(k) clearance on 2020-09-30, under 510(k) number K202376.

Who is the listed applicant for EverLift Submucosal Lifting Agent?

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

What is the FDA product code for EverLift Submucosal Lifting Agent?

The FDA product code for EverLift Submucosal Lifting Agent is PLL.

列明Gi Supply, 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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