FDA 510(k)

GORE SEAMGUARD 生物可吸收线结加固

K号: K181940 · 2018-08-17

决定日期2018-08-17

产品代码OXC

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决定实质等同

器械摘要

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K181940. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K181940.

When did GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement receive FDA 510(k) clearance?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181940.

Who is the listed applicant for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

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

What is the FDA product code for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

The FDA product code for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is OXC.

列明W. L. Gore & 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 K222919GORE® ENFORM 生物材料

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