FDA 510(k)

内窥镜远端附件（AF-D系列）

K号: K242635 · 2025-05-30

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

决定日期2025-05-30

产品代码FDS

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决定实质等同

器械摘要

Endoscopic Distal Attachment (AF-D 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 2025-05-30 under 510(k) number K242635. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoscopic Distal Attachment (AF-D series)?

Endoscopic Distal Attachment (AF-D series) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K242635.

When did Endoscopic Distal Attachment (AF-D series) receive FDA 510(k) clearance?

Endoscopic Distal Attachment (AF-D series) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242635.

Who is the listed applicant for Endoscopic Distal Attachment (AF-D 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 Endoscopic Distal Attachment (AF-D series)?

The FDA product code for Endoscopic Distal Attachment (AF-D series) is FDS.

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）K241679一次性细胞刷（AF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

官方来源

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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。