FDA 510(k)

Endomat Select, IBS Shaver Software, License

K号: K201355 · 2020-07-22

决定日期2020-07-22

产品代码HIG

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决定实质等同

器械摘要

Endomat Select, IBS Shaver Software, License is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K201355. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endomat Select, IBS Shaver Software, License?

Endomat Select, IBS Shaver Software, License is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K201355.

When did Endomat Select, IBS Shaver Software, License receive FDA 510(k) clearance?

Endomat Select, IBS Shaver Software, License received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201355.

Who is the listed applicant for Endomat Select, IBS Shaver Software, License?

FDA 510(k)记录中列出Karl Storz SE & CO. KG为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Endomat Select, IBS Shaver Software, License?

The FDA product code for Endomat Select, IBS Shaver Software, License is HIG.

列明Karl Storz SE & CO. KG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。

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）K254303KARL STORZ SUPRALOOP K261102UNIDRIVE选择系统 K254299清晰视野冲洗套管 0°（7241AS）；清晰视野冲洗套管 30°（7241BS）；清晰视野冲洗套管 45°（7241FS）K260884UNIDRIVE选择系统 K254103霍普金斯关节镜望远镜

查看所有 33 个设备 →

相关器械（代码：HIG）

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。

K261706Endomat Select (UP220)KARL STORZ SE & CO. KG K251273Asurys 流体管理系统Boston Scientific Corporation K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO 液体管理系统Thermedx, LLC K180735Endomat SelectKarl Storz SE & CO. KG K180825Fluent Fluid Management SystemHologic, Inc.

官方来源

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