FDA 510(k)

多功能电外科刀

K号: K212999 · 2022-03-21

决定日期2022-03-21

产品代码KNS

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Multi-Functional Electrosurgical Knife is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-03-21 under 510(k) number K212999. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Multi-Functional Electrosurgical Knife?

Multi-Functional Electrosurgical Knife is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K212999.

When did Multi-Functional Electrosurgical Knife receive FDA 510(k) clearance?

Multi-Functional Electrosurgical Knife received FDA 510(k) clearance on 2022-03-21, under 510(k) number K212999.

Who is the listed applicant for Multi-Functional Electrosurgical Knife?

The FDA 510(k) record lists Anrei Medical (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Functional Electrosurgical Knife?

The FDA product code for Multi-Functional Electrosurgical Knife is KNS.

列明Anrei Medical (Hangzhou) 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。

K210917一次性注射针 K202987Rescue 肺部抓握镊子 K210660结石取出球囊导管 K201771单次使用可旋转和可重新定位的血液夹 K192048一次性内窥镜阀门套装

相关器械（代码：KNS）

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。

K262460Rezum系统Boston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388征服水蒸气消融装置Francis Medical, Inc.K252889一次性3腔针刀V（KD-V441M，KD-V451M）Olympus Medical Systems Corporation K250945一次性预装括约肌刀V（远端导丝引导）（KD-VC600系列）；一次性括约肌刀V（远端导丝引导）（KD-VC400系列）；一次性三腔括约肌刀（KD-V系列）；一次性三腔括约肌刀（KD系列）Olympus Medical Systems Corp.K250351一次性电外科刀 (KD-612L, KD-612U)；一次性电外科刀 (KD-620UR)；一次性电外科刀 (KD-650L, KD-650U)Olympus Medical Systems 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。