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FDA 510(k)

Neoscope 3D - 3D 数字视频内窥镜系统（刚性/柔性）

K号: K152619 · 2016-04-29

申请人Prosurg, Inc.
决定日期2016-04-29
产品代码GCJ
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

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152619. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Prosurg, Inc.. The 510(k) number is K152619.

When did Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) receive FDA 510(k) clearance?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152619.

Who is the listed applicant for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA 510(k) record lists Prosurg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is GCJ.

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Prosurg, 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。

K152511Neo - 硬式关节镜（2.0mm/3.5mm），外鞘/套管，带手柄的外鞘/套管，外鞘/套管刺刀K152466Neo-Bronchoscope - 数字视频支气管镜系统（硬式/软式）

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE选择系统Karl Storz SE & CO. KGK260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony CorporationK261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLCK253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical ImpactK261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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