FDA 510(k)

Monarch平台，泌尿科

K号: K213334 · 2022-04-29

决定日期2022-04-29

产品代码FGB

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决定实质等同

器械摘要

Monarch Platform, Urology is the device name listed in this FDA 510(k) record. The listed applicant is Auris Health, Inc.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K213334. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Monarch Platform, Urology?

Monarch Platform, Urology is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Auris Health, Inc.. The 510(k) number is K213334.

When did Monarch Platform, Urology receive FDA 510(k) clearance?

Monarch Platform, Urology received FDA 510(k) clearance on 2022-04-29, under 510(k) number K213334.

Who is the listed applicant for Monarch Platform, Urology?

FDA 510(k)记录中列出Auris Health, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Monarch Platform, Urology?

The FDA product code for Monarch Platform, Urology is FGB.

列明Auris Health, 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。

K260382MONARCH™ 平台（MON-000008）K243219MONARCH™ 平台（MON-000008）K211493Monarch平台 K193534Monarch平台

相关器械（代码：FGB）

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。

K261447CVAC® 吸引系统Calyxo, Inc.K262488一次性使用视频软性输尿管肾镜（RP-U-C06R9，RP-U-C06R3，RP-U-C06S9，RP-U-C06S3）Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite 数字柔性输尿管镜系统Boston Scientific Corporation K262552一次性使用柔性输尿管镜（一次性使用柔性输尿管镜：SUV-5C-B）Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView 单次使用数字柔性膀胱镜（C38-CS，C38-CRS，C50-C，C50-CR，C50-CB，C50-CBR）MacroLux Medical Technology Co., Ltd.

官方来源

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