FDA 510(k)

达芬奇X/Xi 8mm 内窥镜增强型，0，达芬奇X/Xi 8mm 内窥镜增强型，30

K号: K191736 · 2019-07-26

决定日期2019-07-26

产品代码NAY

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决定实质等同

器械摘要

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191736. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30?

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Intuitive Surgical. The 510(k) number is K191736.

When did da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 receive FDA 510(k) clearance?

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191736.

Who is the listed applicant for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30?

The FDA 510(k) record lists Intuitive Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30?

The FDA product code for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 is NAY.

列明Intuitive Surgical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。

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官方来源

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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。