一次性细胞刷 V (BC-V600P-3010)
K号: K250993 · 2025-12-18
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决定日期2025-12-18
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
Single Use Cytology Brush V (BC-V600P-3010) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K250993. 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 Single Use Cytology Brush V (BC-V600P-3010)?
Single Use Cytology Brush V (BC-V600P-3010) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250993.
When did Single Use Cytology Brush V (BC-V600P-3010) receive FDA 510(k) clearance?
Single Use Cytology Brush V (BC-V600P-3010) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K250993.
Who is the listed applicant for Single Use Cytology Brush V (BC-V600P-3010)?
FDA 510(k)记录显示，Olympus Medical Systems Corporation为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Single Use Cytology Brush V (BC-V600P-3010)?
The FDA product code for Single Use Cytology Brush V (BC-V600P-3010) is FDX.
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Olympus Medical Systems 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：FDX）
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。
K220063一次性细胞刷Zhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485可弯曲刷活检套装Cook IncorporatedK182231刷活检套装；可弯曲刷活检套装Cook IncorporatedK181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.K172663细胞学刷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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