FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

K号: K181317 · 2019-02-08

决定日期2019-02-08

产品代码FDX

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

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K181317. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K181317.

When did Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush receive FDA 510(k) clearance?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush received FDA 510(k) clearance on 2019-02-08, under 510(k) number K181317.

Who is the listed applicant for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

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

What is the FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

The FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is FDX.

列明Wilson-Cook 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。

K253302Hemospray 内镜止血夹 (HEMO-[X])K243568Teslatome 双极肛门括约肌刀；Tesla BiCord 主动线缆 K213356Entuit PEG，Entuit PEGJ K212323Instinct Plus Endoscopic Clipping Device K201322Entuit 鼻空肠喂养管 K200972Hemospray 内镜止血夹

查看所有 32 个设备 →

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。