FDA 510(k)

达芬奇SP手术系统（SP1098）；达芬奇E-200发生器

K号: K253556 · 2026-01-16

决定日期2026-01-16

产品代码NAY

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决定实质等同

器械摘要

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator 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 2026-01-16 under 510(k) number K253556. 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 SP Surgical System (SP1098); da Vinci E-200 Generator?

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K253556.

When did da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator receive FDA 510(k) clearance?

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253556.

Who is the listed applicant for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator?

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 da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator?

The FDA product code for da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator is NAY.

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）

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官方来源

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