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FDA 510(k)

Web II 记忆提取篮或记忆 II 双腔提取篮，记忆 5 Fr 软丝篮或记忆螺旋结石提取器，记忆八丝篮或记忆硬丝篮，融合丝引导提取篮，非碎石提取篮

K号: K171969 · 2018-03-28

申请人Wilson-Cook Medical, Inc.
决定日期2018-03-28
产品代码LQR
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

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket 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 2018-03-28 under 510(k) number K171969. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket?

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K171969.

When did Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket receive FDA 510(k) clearance?

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket received FDA 510(k) clearance on 2018-03-28, under 510(k) number K171969.

Who is the listed applicant for Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket?

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 Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket?

The FDA product code for Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket is LQR.

相关临床试验

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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 PEGJK212323Instinct Plus Endoscopic Clipping DeviceK201322Entuit 鼻空肠喂养管K200972Hemospray 内镜止血夹

查看所有 32 个设备 →

相关器械（代码：LQR）

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。

K253056一次性结石取出篮Zhejiang Soudon Medical Technology Co., Ltd.K243807单次使用检索篮 V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471提取篮Micro-Tech (Nanjing) Co., Ltd.K240192一次性使用提取篮Scivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover回收篮Boston Scientific Corporation

官方来源

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