FDA 510(k)

輸尿管支架（AF-D系列）

K 號：K243039 · 2025-06-18

申請人Alton (Shanghai) Medical Instruments Co., Ltd.

決定日期2025-06-18

產品代碼FAD

諮詢委員會GU

決定相當於

器材摘要

Ureteral Stents (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 2025-06-18 under 510(k) number K243039. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ureteral Stents (AF-D series)?

Ureteral Stents (AF-D series) is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K243039.

When did Ureteral Stents (AF-D series) receive FDA 510(k) clearance?

Ureteral Stents (AF-D series) received FDA 510(k) clearance on 2025-06-18, under 510(k) number K243039.

Who is the listed applicant for Ureteral Stents (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 Ureteral Stents (AF-D series)?

The FDA product code for Ureteral Stents (AF-D series) is FAD.

其他以 Alton (Shanghai) Medical Instruments Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242635內視鏡遠端附件（AF-D系列）K241679一次性細胞學刷（AF系列）K241285一次性內視鏡閥門組合（AF系列）K231633一次性血夾（AF系列）K230925一次性注射針 AF 系列

相關器械（代碼：FAD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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