FDA 510(k)

OES ELITE 输尿管镜及其附件

K号: K200369 · 2020-08-28

决定日期2020-08-28

产品代码FGB

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

OES Elite Ureteroscopes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K200369. 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 OES Elite Ureteroscopes and Accessories?

OES Elite Ureteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K200369.

When did OES Elite Ureteroscopes and Accessories receive FDA 510(k) clearance?

OES Elite Ureteroscopes and Accessories received FDA 510(k) clearance on 2020-08-28, under 510(k) number K200369.

Who is the listed applicant for OES Elite Ureteroscopes and Accessories?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OES Elite Ureteroscopes and Accessories?

The FDA product code for OES Elite Ureteroscopes and Accessories is FGB.

列明Olympus Winter & Ibe 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。

K260649OES ELITE 球囊内镜及其附件；球囊，17 Fr. (WA2C17BO)；球囊，19.8 Fr. (WA2C19BO)；球囊，21 Fr. (WA2C21BO)；球囊，21 Fr.，用于带斜坡的套管 (WA2C21RO)；球囊，21 Fr.，长 (WA2C21LO)；球囊，21 Fr.，用于直型套管 (WA2C21SO)；球囊，22.5 Fr. (WA2C22BO)；球囊，25 Fr. (WA2C25BO)；光学球囊，19.8 Fr. (WA2C19BV)；光学球囊，21 Fr. (WA2C21BV)；光学球囊，21 Fr.，用于直型套管 (WA2C21SV)；光学球囊，K252043双极治疗仪CelonProBreath (WB990310)；双极治疗仪CelonProSleep plus (WB990311)；双极治疗仪CelonProBreath (WB990210)；双极治疗仪CelonProSleep plus (WB990211)K231777电外科手术发生器 ESG-410 及附件（WA91327U，WA91327W），附件：脚踏开关（WA91311W，WA91321W）K221522HF-cables（可重复使用）K223183光导电缆 K213207套管，旋塞附件

查看所有 22 个设备 →

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

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。