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FDA 510(k)

Biodesign 肛门瘘管塞，Biodesign 瘘管塞，Biodesign 整形外科基质，Biodesign 组织移植

K号: K191696 · 2019-12-27

申请人Cook Biotech Incorporated
决定日期2019-12-27
产品代码OXN
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft 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 2019-12-27 under 510(k) number K191696. The device is classified under product code OXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K191696.

When did Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft receive FDA 510(k) clearance?

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft received FDA 510(k) clearance on 2019-12-27, under 510(k) number K191696.

Who is the listed applicant for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

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 Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

The FDA product code for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is OXN.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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）K201000Biodesign 线圈加固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。

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