FDA 510(k)

TIPCAM1 Rubina 视频内窥镜系统

K号: K201526 · 2020-11-20

决定日期2020-11-20

产品代码GCJ

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决定实质等同

器械摘要

TIPCAM1 Rubina Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K201526. 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 TIPCAM1 Rubina Video Endoscope System?

TIPCAM1 Rubina Video Endoscope System is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K201526.

When did TIPCAM1 Rubina Video Endoscope System receive FDA 510(k) clearance?

TIPCAM1 Rubina Video Endoscope System received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201526.

Who is the listed applicant for TIPCAM1 Rubina Video Endoscope System?

The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIPCAM1 Rubina Video Endoscope System?

The FDA product code for TIPCAM1 Rubina Video Endoscope System is GCJ.

列明Karl Storz Endoscopy America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。

K212458柔性视频输尿管肾镜SSU系统 K212656柔性气管插管视频内窥镜 - 无菌（FIVE-S）K212695KARL STORZ ICG成像系统 K201001Modulith SLX-F2

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 Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-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 Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

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