FDA 510(k)

MCB 单元型号：V10GMCBUS

K号: K222542 · 2022-09-21

决定日期2022-09-21

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

MCB UNIT Model: V10GMCBUS is the device name listed in this FDA 510(k) record. The listed applicant is Lamidey Noury Medical. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K222542. 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 MCB UNIT Model: V10GMCBUS?

MCB UNIT Model: V10GMCBUS is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Lamidey Noury Medical. The 510(k) number is K222542.

When did MCB UNIT Model: V10GMCBUS receive FDA 510(k) clearance?

MCB UNIT Model: V10GMCBUS received FDA 510(k) clearance on 2022-09-21, under 510(k) number K222542.

Who is the listed applicant for MCB UNIT Model: V10GMCBUS?

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

What is the FDA product code for MCB UNIT Model: V10GMCBUS?

The FDA product code for MCB UNIT Model: V10GMCBUS is KNS.

列明Lamidey Noury Medical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。

K240504PLASMA EDGE 系统

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。