FDA 510(k)

ASPIVIX v1.1 颈部吸切钳

K号: K203820 · 2021-08-17

决定日期2021-08-17

产品代码HDC

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决定实质等同

器械摘要

ASPIVIX v1.1 Cervical Suction Tenaculum is the device name listed in this FDA 510(k) record. The listed applicant is Aspivix SA. It received FDA 510(k) clearance on 2021-08-17 under 510(k) number K203820. The device is classified under product code HDC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ASPIVIX v1.1 Cervical Suction Tenaculum?

ASPIVIX v1.1 Cervical Suction Tenaculum is a medical device that received FDA 510(k) clearance on 2021-08-17. The listed applicant is Aspivix SA. The 510(k) number is K203820.

When did ASPIVIX v1.1 Cervical Suction Tenaculum receive FDA 510(k) clearance?

ASPIVIX v1.1 Cervical Suction Tenaculum received FDA 510(k) clearance on 2021-08-17, under 510(k) number K203820.

Who is the listed applicant for ASPIVIX v1.1 Cervical Suction Tenaculum?

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

What is the FDA product code for ASPIVIX v1.1 Cervical Suction Tenaculum?

The FDA product code for ASPIVIX v1.1 Cervical Suction Tenaculum is HDC.

列明Aspivix SA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。

K223866Carevix® 吸引宫颈稳定器

官方来源

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