FDA 510(k)

Endoscope Sterilization Tray

K号: K151450 · 2016-01-12

决定日期2016-01-12

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Endoscope Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K151450. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoscope Sterilization Tray?

Endoscope Sterilization Tray is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K151450.

When did Endoscope Sterilization Tray receive FDA 510(k) clearance?

Endoscope Sterilization Tray received FDA 510(k) clearance on 2016-01-12, under 510(k) number K151450.

Who is the listed applicant for Endoscope Sterilization Tray?

FDA 510(k)记录中列出了Intuitive Surgical, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Endoscope Sterilization Tray?

The FDA product code for Endoscope Sterilization Tray is KCT.

列明Intuitive Surgical, Inc.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。

K261823达芬奇手术系统，型号IS5000 K253702直观内镜胃肠道系统（IG1000）K261824达芬奇手术系统，型号IS5000 K261249通用密封圈（5-12毫米）K253986da Vinci Force Feedback Instruments K253978通用密封圈（5-12毫米）

查看所有 111 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。