FDA 510(k)

KARL STORZ OR1® SCB控制（WU300）

K号: K232406 · 2023-10-03

决定日期2023-10-03

产品代码ODA

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决定实质等同

器械摘要

KARL STORZ OR1™ SCB CONTROL (WU300) 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 2023-10-03 under 510(k) number K232406. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KARL STORZ OR1™ SCB CONTROL (WU300)?

KARL STORZ OR1™ SCB CONTROL (WU300) is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232406.

When did KARL STORZ OR1™ SCB CONTROL (WU300) receive FDA 510(k) clearance?

KARL STORZ OR1™ SCB CONTROL (WU300) received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232406.

Who is the listed applicant for KARL STORZ OR1™ SCB CONTROL (WU300)?

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 KARL STORZ OR1™ SCB CONTROL (WU300)?

The FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300) is ODA.

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

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