Captura® 可弃式热活检镊
K号: K171973 · 2018-03-21
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决定日期2018-03-21
产品代码KGE
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
Captura® Disposable Hot Biopsy Forceps 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 2018-03-21 under 510(k) number K171973. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Captura® Disposable Hot Biopsy Forceps?
Captura® Disposable Hot Biopsy Forceps is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K171973.
When did Captura® Disposable Hot Biopsy Forceps receive FDA 510(k) clearance?
Captura® Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2018-03-21, under 510(k) number K171973.
Who is the listed applicant for Captura® Disposable Hot Biopsy Forceps?
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 Captura® Disposable Hot Biopsy Forceps?
The FDA product code for Captura® Disposable Hot Biopsy Forceps is KGE.
相关临床试验
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。
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。
相关器械（代码：KGE）
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。
K251807一次性电外科止血镊 FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187一次性热活检镊（FD-210U）；一次性热活检镊（FD-230U）Olympus Medical Systems CorporationK242857ClearHemograsperFinemedix Co., Ltd.K231721一次性热活检镊Beijing Zksk Technology Co., Ltd.K220053电热切割机（FlushKnife）DK2620JI和DK2623JIFujifilm CorporationK210406双极电凝镊Hangzhou AGS MedTech Co., Ltd.
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。
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