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FDA 510(k)

Medline ReNewal Reprocessed Sonicision 无线超声解剖器

K号: K170955 · 2017-07-03

申请人Surgical Instrument Service and Savings Inc.(Dba Medline Ren
决定日期2017-07-03
产品代码NLQ
决定实质等同

器械摘要

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2017-07-03 under 510(k) number K170955. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector is a medical device that received FDA 510(k) clearance on 2017-07-03. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K170955.

When did Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170955.

Who is the listed applicant for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

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

What is the FDA product code for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

The FDA product code for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector 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

列明Surgical Instrument Service and Savings Inc.(Dba Medline Ren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。

K241224Medline ReNewal Reprocessed Biosense Webster Webster CS 导管带 EZ Steer 技术，以及 Medline ReNewal Reprocessed Biosense Webster Webster CS 导管带带 EZ Steer 技术和自动 ID 技术（BD710DF282CT，BD710DF282RTS，BD710FJ282RTS，BD710FJ282CT）K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsK182588Medline ReNewal Reprocessed LigaSure 马里兰州颚式密封/分隔器K153745Medline ReNewal Reprocessed LigaSure 影响开放式密封/分隔器K151617Livewire 电生理导管

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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