FDA 510(k)

Rezum输送装置，Rezum发生器

K号: K190093 · 2019-03-25

申请人Nxthera (A Boston Scientific Company)

决定日期2019-03-25

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

Rezum Delivery Device, Rezum Generator is the device name listed in this FDA 510(k) record. The listed applicant is Nxthera (A Boston Scientific Company). It received FDA 510(k) clearance on 2019-03-25 under 510(k) number K190093. 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 Rezum Delivery Device, Rezum Generator?

Rezum Delivery Device, Rezum Generator is a medical device that received FDA 510(k) clearance on 2019-03-25. The listed applicant is Nxthera (A Boston Scientific Company). The 510(k) number is K190093.

When did Rezum Delivery Device, Rezum Generator receive FDA 510(k) clearance?

Rezum Delivery Device, Rezum Generator received FDA 510(k) clearance on 2019-03-25, under 510(k) number K190093.

Who is the listed applicant for Rezum Delivery Device, Rezum Generator?

The FDA 510(k) record lists Nxthera (A Boston Scientific Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rezum Delivery Device, Rezum Generator?

The FDA product code for Rezum Delivery Device, Rezum Generator is KNS.

列明Nxthera (A Boston Scientific Company)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。

K191505Rezum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

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