FDA 510(k)

CUSA Clarity超声手术吸引器系统

K号: K221763 · 2022-07-15

决定日期2022-07-15

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 2022-07-15 under 510(k) number K221763. 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 2022-07-15. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K221763.

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 2022-07-15, under 510(k) number K221763.

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）K240493CUSA® Clarity超声手术吸引器系统 K230427CUSA Clarity超声手术吸引器系统 K221835CUSA 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.K240493CUSA® Clarity超声手术吸引器系统Integra LifeSciences Corporation

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。