FDA 510(k)

CUSA® Clarity超声手术吸引器系统

K号: K240493 · 2024-07-11

决定日期2024-07-11

产品代码LFL

决定实质等同

器械摘要

CUSA® Clarity Ultrasonic Surgical Aspirator System is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2024-07-11 under 510(k) number K240493. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the CUSA® Clarity Ultrasonic Surgical Aspirator System?

CUSA® Clarity Ultrasonic Surgical Aspirator System is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K240493.

When did CUSA® Clarity Ultrasonic Surgical Aspirator System receive FDA 510(k) clearance?

CUSA® Clarity Ultrasonic Surgical Aspirator System received FDA 510(k) clearance on 2024-07-11, under 510(k) number K240493.

Who is the listed applicant for CUSA® Clarity Ultrasonic Surgical Aspirator System?

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

What is the FDA product code for CUSA® Clarity Ultrasonic Surgical Aspirator System?

The FDA product code for CUSA® Clarity Ultrasonic Surgical Aspirator System is LFL.

列明Integra LifeSciences Corporation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。

K251162CUSA® Clarity超声手术吸引器系统 K250752AURORA® Surgiscope® 系统（ASX15/60）；AURORA® Surgiscope® 系统（ASX15/80）K230427CUSA Clarity超声手术吸引器系统 K221835CUSA Clarity超声手术吸引器系统 K221763CUSA Clarity超声手术吸引器系统 K210128INTEGRA Wound Matrix（大通道）

查看所有 28 个设备 →

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.K243930Sonopet iQ 超声波吸引器系统 (5500-050-000)Stryker Instruments K241700Tenex 2代系统Trice Medical, Inc.K233036超声波手术系统Hunan Handlike Minimally Invasive Surgery Co., Ltd.

官方来源

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