FDA 510(k)

ACCUJECT 注射器組 2.1-1P (LP604590)

K 號：K252540 · 2025-09-16

決定日期2025-09-16

產品代碼MSS

諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文：本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。

決定相當於

器材摘要

ACCUJECT Injector Set 2.1-1P (LP604590) is the device name listed in this FDA 510(k) record. The listed applicant is Medicel AG. It received FDA 510(k) clearance on 2025-09-16 under 510(k) number K252540. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACCUJECT Injector Set 2.1-1P (LP604590)?

ACCUJECT Injector Set 2.1-1P (LP604590) is a medical device that received FDA 510(k) clearance on 2025-09-16. The listed applicant is Medicel AG. The 510(k) number is K252540.

When did ACCUJECT Injector Set 2.1-1P (LP604590) receive FDA 510(k) clearance?

ACCUJECT Injector Set 2.1-1P (LP604590) received FDA 510(k) clearance on 2025-09-16, under 510(k) number K252540.

Who is the listed applicant for ACCUJECT Injector Set 2.1-1P (LP604590)?

The FDA 510(k) record lists Medicel AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUJECT Injector Set 2.1-1P (LP604590)?

The FDA product code for ACCUJECT Injector Set 2.1-1P (LP604590) is MSS.

其他以 Medicel AG 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。

K231106Accuject Refra Injector AR2900

相關器械（代碼：MSS）

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。

K261174RxSight® 側入式設備Rxsight, Inc.K242389EyeGility™ 預裝enVista IOLs植入器Bausch & Lomb, Incorporated K231106Accuject Refra Injector AR2900Medicel AG K231838RxSight® 側入式設備（63002）Rxsight, Inc.K231466RxSight植入式設備Rxsight, Inc.K212039CLAREON MONARCH IV IOL 選送系統Alcon Laboratories, Inc.

官方來源

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