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FDA 510(k)

Medline ReNewal Reprocessed Harmonic ACE + Shears 无自适应组织技术

K号: K151405 · 2016-01-26

申请人Surgical Instrument Services and Savings(Dba Medline Renewal
决定日期2016-01-26
产品代码NLQ
决定实质等同

器械摘要

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Services and Savings(Dba Medline Renewal. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K151405. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology?

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Surgical Instrument Services and Savings(Dba Medline Renewal. The 510(k) number is K151405.

When did Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology received FDA 510(k) clearance on 2016-01-26, under 510(k) number K151405.

Who is the listed applicant for Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology?

The FDA 510(k) record lists Surgical Instrument Services and Savings(Dba Medline Renewal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology?

The FDA product code for Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology is NLQ.

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

相关器械（代码：NLQ）

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。

K250898再处理的HARMONIC 700剪（HAR723/再处理的HARMONIC 700，5mm直径剪，高级止血x 23cm）；再处理的HARMONIC 700剪（HAR736/再处理的HARMONIC 700，5mm直径剪，高级止血x 36cm）；再处理的HARMONIC 700剪（HAR745/再处理的HARMONIC 700，5mm直径剪，高级止血x 45cm）Stryker Sustainability SolutionsK241606再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）Stryker Sustainability SolutionsK233471再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）Stryker Sustainability SolutionsK202554再处理的HARMONIC ACE+ 7，5 mm直径剪，具有高级止血功能Stryker Sustainability SolutionsK193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline RenK190610再处理的HARMONIC FOCUS剪 + 自适应组织技术Sterilmed, Inc.

官方来源

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