一次性热活检镊
K号: K231721 · 2023-12-14
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决定日期2023-12-14
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
Disposable Hot Biopsy Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K231721. 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 Disposable Hot Biopsy Forceps?
Disposable Hot Biopsy Forceps is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Beijing Zksk Technology Co., Ltd.. The 510(k) number is K231721.
When did Disposable Hot Biopsy Forceps receive FDA 510(k) clearance?
Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2023-12-14, under 510(k) number K231721.
Who is the listed applicant for Disposable Hot Biopsy Forceps?
The FDA 510(k) record lists Beijing Zksk Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Hot Biopsy Forceps?
The FDA product code for 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Beijing Zksk Technology Co., Ltd.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.K220053电热切割机（FlushKnife）DK2620JI和DK2623JIFujifilm CorporationK210406双极电凝镊Hangzhou AGS MedTech Co., Ltd.K202438Ensure 单次使用凝血镊Micro-Tech (Nanjing) 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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