FDA 510(k)

Resolv 内镜止血夹系统

K号: K234131 · 2024-07-26

决定日期2024-07-26

产品代码QAU

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Resolv Endoscopic Hemostat System is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K234131. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Resolv Endoscopic Hemostat System?

Resolv Endoscopic Hemostat System is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Hemostasis, LLC. The 510(k) number is K234131.

When did Resolv Endoscopic Hemostat System receive FDA 510(k) clearance?

Resolv Endoscopic Hemostat System received FDA 510(k) clearance on 2024-07-26, under 510(k) number K234131.

Who is the listed applicant for Resolv Endoscopic Hemostat System?

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

What is the FDA product code for Resolv Endoscopic Hemostat System?

The FDA product code for Resolv Endoscopic Hemostat System is QAU.

列明Hemostasis, LLC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。

K220326PosiSep X BAM 止血敷料/鼻内夹板 K210411PosiSep 耳部可碎性敷料

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。