FDA 510(k)

Biodesign 线圈加固

K号: K201000 · 2020-07-13

决定日期2020-07-13

产品代码FTM

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决定实质等同

器械摘要

Biodesign Staple Line Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2020-07-13 under 510(k) number K201000. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biodesign Staple Line Reinforcement?

Biodesign Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K201000.

When did Biodesign Staple Line Reinforcement receive FDA 510(k) clearance?

Biodesign Staple Line Reinforcement received FDA 510(k) clearance on 2020-07-13, under 510(k) number K201000.

Who is the listed applicant for Biodesign Staple Line Reinforcement?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodesign Staple Line Reinforcement?

The FDA product code for Biodesign Staple Line Reinforcement is FTM.

列明Cook Biotech Incorporated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。

K232646Biodesign 耳科蝴蝶移植（ENT-OTO-BFLY-0.4-0.6）；Biodesign 耳科蝴蝶移植（ENT-OTO-BFLY-0.6-0.9）K191696Biodesign 肛门瘘管塞，Biodesign 瘘管塞，Biodesign 整形外科基质，Biodesign 组织移植 K171817Biodesign 膈肌裂孔移植 K162934Biodesign 肠造口旁疝修复移植 K170016Biodesign 瘘管塞 K170945Biodesign 线圈加固

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。