FDA 510(k)

Accuro® 3S 针引导套件

K号: K250469 · 2025-06-13

决定日期2025-06-13

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

Accuro® 3S Needle Guide Kit is the device name listed in this FDA 510(k) record. The listed applicant is Rivanna Medical, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250469. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是Accuro® 3S针引导套件？

Accuro® 3S Needle Guide Kit is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Rivanna Medical, Inc.. The 510(k) number is K250469.

Accuro® 3S针引导套件何时获得FDA 510(k)批准？

Accuro® 3S Needle Guide Kit received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250469.

Accuro® 3S针引导套件列出的申请人是谁？

FDA 510(k)记录中列出Rivanna Medical, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

Accuro® 3S针引导套件在FDA的产品代码是什么？

Accuro® 3S 针引导套件在FDA的产品代码是ITX。

列明Rivanna Medical, 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。

K253452Accuro 3S K261014Accuro® 3S 针引导套件 K254021Accuro XV K243937Accuro 3S

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。