FDA 510(k)

Stasis凝胶

K号: K211420 · 2022-03-14

决定日期2022-03-14

产品代码MVL

决定实质等同

器械摘要

Stasis Gel is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K211420. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

常见问题

What is the Stasis Gel?

Stasis Gel is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K211420.

When did Stasis Gel receive FDA 510(k) clearance?

Stasis Gel received FDA 510(k) clearance on 2022-03-14, under 510(k) number K211420.

Who is the listed applicant for Stasis Gel?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stasis Gel?

The FDA product code for Stasis Gel is MVL.

列明Belport Company, Inc., Gingi-Pak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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