FDA 510(k)

GORE® ENFORM 生物材料

K号: K222919 · 2022-12-19

决定日期2022-12-19

产品代码OXF

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决定实质等同

器械摘要

GORE® ENFORM Biomaterial is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) number K222919. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GORE® ENFORM Biomaterial?

GORE® ENFORM Biomaterial is a medical device that received FDA 510(k) clearance on 2022-12-19. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K222919.

When did GORE® ENFORM Biomaterial receive FDA 510(k) clearance?

GORE® ENFORM Biomaterial received FDA 510(k) clearance on 2022-12-19, under 510(k) number K222919.

Who is the listed applicant for GORE® ENFORM Biomaterial?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE® ENFORM Biomaterial?

The FDA product code for GORE® ENFORM Biomaterial is OXF.

列明W. L. Gore and Associates, 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。

K250410GORE® 三叶球囊导管 K240083GORE® PROPATEN® 血管移植物 K232312GORE® PROPATEN® 血管移植物 K233551GORE® ACUSEAL 血管移植物 K231505GORE® ACUSEAL 血管移植物 K191773GORE BIO-A 组织加强

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官方来源

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