FDA 510(k)

Schoelly膀胱镜/宫腔镜及其附件

K号: K201970 · 2020-10-08

决定日期2020-10-08

产品代码HIH

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Schoelly Cystoscopes/Hysteroscopes and Accessories 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 2020-10-08 under 510(k) number K201970. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Schoelly Cystoscopes/Hysteroscopes and Accessories?

Schoelly Cystoscopes/Hysteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K201970.

When did Schoelly Cystoscopes/Hysteroscopes and Accessories receive FDA 510(k) clearance?

Schoelly Cystoscopes/Hysteroscopes and Accessories received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201970.

Who is the listed applicant for Schoelly Cystoscopes/Hysteroscopes and Accessories?

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 Cystoscopes/Hysteroscopes and Accessories?

The FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories is HIH.

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））K151308Schoelly肾镜套装，Schoelly超迷你肾镜套装

相关器械（代码：HIH）

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。

K254252UNIDRIVE SIII 系统；霍普金斯望远镜 0º（26205AMA）操作套管（26205CD）闭孔器（26205OC）剃刀刀片（26205SA）剃刀刀片（26205SB）剃刀刀片（091133-01/-10）剃刀刀片（091134-01/-10）Karl Storz SE & CO. KG K261102UNIDRIVE选择系统Karl Storz SE & CO. KG K254294一次性使用数字宫腔镜（GYUT-A 12.6- 0，GYUT-A12.6- 12，GYUT-A 12.6- 22，GYUT-A 12.6- 30，GYUT-A 14.4- 0，GYUT-A 14.4- 12，GYUT-A 14.4- 22，GYUT-A 14.4- 30，GYUT-B 15- 0，GYUT-B 15- 12，GYUT-B 15-22，GYUT-B 15- 30）Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 切除装置（5FR1PK）；HERizon RD5 切除装置 - 5套装（5FR5PK）Axora Medical, Inc.K253020Strauss Surgical切除工具American Medical Endoscopy, Inc.K254050手动组织移除装置Suzhou AcuVu 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。