FDA 510(k)

Sonopet iQ 超声波吸引器系统 (5500-050-000)

K号: K243930 · 2025-03-24

决定日期2025-03-24

产品代码LFL

决定实质等同

器械摘要

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243930. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Stryker Instruments. The 510(k) number is K243930.

When did Sonopet iQ Ultrasonic Aspirator System (5500-050-000) receive FDA 510(k) clearance?

Sonopet iQ Ultrasonic Aspirator System (5500-050-000) received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243930.

Who is the listed applicant for Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

FDA 510(k)记录中列出Stryker Instruments为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Sonopet iQ Ultrasonic Aspirator System (5500-050-000)?

The FDA product code for Sonopet iQ Ultrasonic Aspirator System (5500-050-000) is LFL.

列明Stryker Instruments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。

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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。

K261448neXus 超声手术吸引器系统Misonix, LLC K251162CUSA® Clarity超声手术吸引器系统Integra LifeSciences Corporation K242894SanAgile® 超声手术高级便携式控制器 (SA10)；SanAgile® 超声手术高级解剖器 (SASD14)；SanAgile® 超声手术高级解剖器 (SASD23)；SanAgile® 超声手术高级解剖器 (SASD36)；SanAgile® 超声手术高级解剖器 (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K241700Tenex 2代系统Trice Medical, Inc.K240493CUSA® Clarity超声手术吸引器系统Integra LifeSciences Corporation K233036超声波手术系统Hunan Handlike Minimally Invasive Surgery Co., Ltd.

官方来源

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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。