FDA 510(k)

PuraStat-GI

K号: K210098 · 2021-06-25

决定日期2021-06-25

产品代码QAU

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决定实质等同

器械摘要

PuraStat-GI is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K210098. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PuraStat-GI?

PuraStat-GI is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K210098.

When did PuraStat-GI receive FDA 510(k) clearance?

PuraStat-GI received FDA 510(k) clearance on 2021-06-25, under 510(k) number K210098.

Who is the listed applicant for PuraStat-GI?

FDA 510(k)记录显示3-D Matrix，Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for PuraStat-GI?

The FDA product code for PuraStat-GI is QAU.

列明3-D Matrix, 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。

K261503PuraStat 胃肠 K261504PuraStat-RM K222481PuraStat K213552PuraStat-RM K210211PuraStat-OM K193085PuraDERM凝胶

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官方来源

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