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FDA 510(k)

Medline ReNewal Reprocessed Endopath 内窥镜器械

K号: K152313 · 2016-01-06

申请人Surgical Instrument Services and Savings, Inc.
决定日期2016-01-06
产品代码NUJ
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

Medline ReNewal Reprocessed Endopath Endoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Services and Savings, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K152313. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline ReNewal Reprocessed Endopath Endoscopic Instruments?

Medline ReNewal Reprocessed Endopath Endoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Surgical Instrument Services and Savings, Inc.. The 510(k) number is K152313.

When did Medline ReNewal Reprocessed Endopath Endoscopic Instruments receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Endopath Endoscopic Instruments received FDA 510(k) clearance on 2016-01-06, under 510(k) number K152313.

Who is the listed applicant for Medline ReNewal Reprocessed Endopath Endoscopic Instruments?

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

What is the FDA product code for Medline ReNewal Reprocessed Endopath Endoscopic Instruments?

The FDA product code for Medline ReNewal Reprocessed Endopath Endoscopic Instruments is NUJ.

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 Services and Savings, 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。

K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE 导管K162751Medline ReNewal Reprocessed Ligasure 弯曲，小颚开放式密封/分隔器

相关器械（代码：NUJ）

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。

K232511Medline ReNewal Reprocessed LigaSure 精确分离器，纳米涂层（LF2019）Surgical Instrument Service and Savings, Inc.K230251再处理的LigaSure弯曲，小口，开放式密封/分离器（LF1212A）Stryker Sustainability SolutionsK220411再处理的LigaSure弯曲，小口，开放式密封/分离器（LF1212A）Stryker Sustainability SolutionsK211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLCK191073Vein360 静脉射频消融（RFA）导管Vein 360, LLCK182588Medline ReNewal Reprocessed LigaSure 马里兰州颚式密封/分隔器Surgical Instrument Service and Savings Inc.(Dba Medline Ren

官方来源

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