FDA 510(k)

ENDOFLATOR +

K号: K250388 · 2025-09-22

决定日期2025-09-22

产品代码HIF

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

ENDOFLATOR + 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 2025-09-22 under 510(k) number K250388. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ENDOFLATOR +?

ENDOFLATOR + is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K250388.

When did ENDOFLATOR + receive FDA 510(k) clearance?

ENDOFLATOR + received FDA 510(k) clearance on 2025-09-22, under 510(k) number K250388.

Who is the listed applicant for ENDOFLATOR +?

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 ENDOFLATOR +?

The FDA product code for ENDOFLATOR + is HIF.

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 →

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。