FDA 510(k)

超声波手术系统

K号: K233036 · 2024-06-18

申请人Hunan Handlike Minimally Invasive Surgery Co., Ltd.

决定日期2024-06-18

产品代码LFL

决定实质等同

器械摘要

Ultrasonic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K233036. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasonic Surgical System?

Ultrasonic Surgical System is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. The 510(k) number is K233036.

When did Ultrasonic Surgical System receive FDA 510(k) clearance?

Ultrasonic Surgical System received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233036.

Who is the listed applicant for Ultrasonic Surgical System?

The FDA 510(k) record lists Hunan Handlike Minimally Invasive Surgery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Surgical System?

The FDA product code for Ultrasonic Surgical System is LFL.

列明Hunan Handlike Minimally Invasive Surgery Co., Ltd.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。

K171825一次性内镜手术器械，可重复使用内镜手术器械

相关器械（代码：LFL）

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。

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官方来源

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