电热切割机（FlushKnife）DK2620JI和DK2623JI
K号: K220053 · 2022-02-04
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决定日期2022-02-04
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
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K220053. 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 Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Fujifilm Corporation. The 510(k) number is K220053.
When did Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI receive FDA 510(k) clearance?
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI received FDA 510(k) clearance on 2022-02-04, under 510(k) number K220053.
Who is the listed applicant for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?
FDA 510(k)记录中列出富士胶片公司为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI?
The FDA product code for Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI 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Fujifilm Corporation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.K210406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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