FDA 510(k)

Schoelly肾镜套装，Schoelly超迷你肾镜套装

K号: K151308 · 2016-02-09

决定日期2016-02-09

产品代码FGA

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决定实质等同

器械摘要

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151308. The device is classified under product code FGA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K151308.

When did Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set receive FDA 510(k) clearance?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151308.

Who is the listed applicant for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

The FDA product code for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is FGA.

列明Schoelly Fiberoptic GmbH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。

K233225SCHOELLY 氧饱和度成像 (OSI) 摄像机系统（摄像机控制单元，摄像机头需连接到光纤内窥镜）K221591摄像头系统（摄像头控制单元，摄像头头连接到光纤内窥镜），NIR FI 光源 K201617TipVision 视频内窥镜系统（TipVision 视频内窥镜 0°/30°；EleVision HD 2 摄像机控制单元（CCU））K201970Schoelly膀胱镜/宫腔镜及其附件

官方来源

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