免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Medline ReNewal Reprocessed Versaport V2 无刀片光学套管

K号: K153258 · 2016-04-05

申请人Surgical Instrument Service and Savings (Dba Medline Renewal
决定日期2016-04-05
产品代码NLM
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings (Dba Medline Renewal. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K153258. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Surgical Instrument Service and Savings (Dba Medline Renewal. The 510(k) number is K153258.

When did Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars received FDA 510(k) clearance on 2016-04-05, under 510(k) number K153258.

Who is the listed applicant for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

The FDA 510(k) record lists Surgical Instrument Service 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 Versaport V2 Bladeless Optical Trocars?

The FDA product code for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is NLM.

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：NLM）

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。

K201511再处理的内窥镜套管和袖套Stryker Sustainability SolutionsK182828Medline ReNewal Reprocessed Carter-Thomason 针尖缝合线通过器Surgical Instrument Service and Savings, Inc.K172097再处理的Ethicon无刀套管；再处理的Ethicon通用套管袖套Renovo, Inc.K172093再生处理Covidien套管Renovo, Inc.K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar 带OPTIVIEW 技术Surgical Instrument Service and Savings, Inc.

官方来源

在 FDA 数据库中查看 →

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。

↑