FDA 510(k)

一次性细胞刷（AF系列）

K号: K241679 · 2025-03-04

申请人Alton (Shanghai) Medical Instruments Co., Ltd.

决定日期2025-03-04

产品代码KTI

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

Disposable Cytology Brush (AF series) is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-03-04 under 510(k) number K241679. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Cytology Brush (AF series)?

Disposable Cytology Brush (AF series) is a medical device that received FDA 510(k) clearance on 2025-03-04. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K241679.

When did Disposable Cytology Brush (AF series) receive FDA 510(k) clearance?

Disposable Cytology Brush (AF series) received FDA 510(k) clearance on 2025-03-04, under 510(k) number K241679.

Who is the listed applicant for Disposable Cytology Brush (AF series)?

The FDA 510(k) record lists Alton (Shanghai) Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Cytology Brush (AF series)?

The FDA product code for Disposable Cytology Brush (AF series) is KTI.

列明Alton (Shanghai) Medical Instruments 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。

K243039输尿管支架（AF-D系列）K242635内窥镜远端附件（AF-D系列）K241285一次性内镜阀门组件套件（AF系列）K231633一次性止血夹（AF系列）K230925一次性注射针 AF 系列

相关器械（代码：KTI）

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。

K261274EchoTip Ultra® 内镜超声活检针，适用于富士胶片内窥镜；EchoTip ProCore® 内镜超声活检针，适用于富士胶片内窥镜Cook Ireland, Ltd.K251478ClearTip TBNA 类型Finemedix Co., Ltd.K254040LungFlow篮状导管Free Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass可调针，配备适配器SRA-1-01和SRA-2-01Serpex Medical, Inc.K251664一次性吸引针（NA-201SX-4021）；一次性吸引针（NA-201SX-4022）Olympus Medical Systems Corporation

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。