FDA 510(k)

TP Pivot Pro™ 针头引导器

K号: K233109 · 2023-12-22

决定日期2023-12-22

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

TP Pivot Pro™ Needle Guide is the device name listed in this FDA 510(k) record. The listed applicant is Civco Medical Solutions. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233109. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TP Pivot Pro™ Needle Guide?

TP Pivot Pro™ Needle Guide is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Civco Medical Solutions. The 510(k) number is K233109.

When did TP Pivot Pro™ Needle Guide receive FDA 510(k) clearance?

TP Pivot Pro™ Needle Guide received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233109.

Who is the listed applicant for TP Pivot Pro™ Needle Guide?

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

What is the FDA product code for TP Pivot Pro™ Needle Guide?

The FDA product code for TP Pivot Pro™ Needle Guide is ITX.

列明Civco Medical Solutions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。

K190802Envision 超声垫和盖

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