FDA 510(k)

刷活检套装；可弯曲刷活检套装

K号: K182231 · 2019-05-01

决定日期2019-05-01

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

Brush Biopsy Set ; Deflectable Brush Biopsy Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K182231. 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 Brush Biopsy Set ; Deflectable Brush Biopsy Set?

Brush Biopsy Set ; Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Cook Incorporated. The 510(k) number is K182231.

When did Brush Biopsy Set ; Deflectable Brush Biopsy Set receive FDA 510(k) clearance?

Brush Biopsy Set ; Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-05-01, under 510(k) number K182231.

Who is the listed applicant for Brush Biopsy Set ; Deflectable Brush Biopsy Set?

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

What is the FDA product code for Brush Biopsy Set ; Deflectable Brush Biopsy Set?

The FDA product code for Brush Biopsy Set ; Deflectable Brush Biopsy Set is FDX.

列明Cook Incorporated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。

K233177Nest VT 液化设备 K222254Gunther郁金香下腔静脉滤器回收套件 K223098Bakri Essential Postpartum Balloon K210734血管内扩张器和套装 K203670超大号Check-Flo导引器 K191498Cook-Cope 环形肾造口套装，Ultrathane 肾造口套装带 Mac-Loc，Ultrathane 腹股沟套装带 Mac-Loc

查看所有 146 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。