FDA 510(k)

Tenex 2代系统

K号: K241700 · 2024-11-18

决定日期2024-11-18

产品代码LFL

决定实质等同

器械摘要

Tenex 2nd Generation System is the device name listed in this FDA 510(k) record. The listed applicant is Trice Medical, Inc.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K241700. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the Tenex 2nd Generation System?

Tenex 2nd Generation System is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Trice Medical, Inc.. The 510(k) number is K241700.

When did Tenex 2nd Generation System receive FDA 510(k) clearance?

Tenex 2nd Generation System received FDA 510(k) clearance on 2024-11-18, under 510(k) number K241700.

Who is the listed applicant for Tenex 2nd Generation System?

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

What is the FDA product code for Tenex 2nd Generation System?

The FDA product code for Tenex 2nd Generation System is LFL.

列明Trice Medical, Inc.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。

K212556mi-eye 3 带导管内窥镜，mi-tablet 3

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 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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