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FDA 510(k)

Alexis® 補光式傷口保護器-拉開器，硬質，中（CL402）；Alexis® 補光式傷口保護器-拉開器，柔軟，中（CL302）

K 號：K253531 · 2026-02-23

申請人Applied Medical Resources Corporation
決定日期2026-02-23
產品代碼KGW
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253531. The device is classified under product code KGW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)?

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K253531.

When did Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) receive FDA 510(k) clearance?

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253531.

Who is the listed applicant for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)?

The FDA product code for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) is KGW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Applied Medical Resources Corporation 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。

K260982Alexis 補光式傷口保護器-拉開器，柔軟，特小（cl312）；Alexis 補光式傷口保護器-拉開器，柔軟，小（cl301）；Alexis 補光式傷口保護器-拉開器，柔軟，中（cl302）；Alexis 補光式傷口保護器-拉開器，柔軟，大（cl303）；Alexis 補光式傷口保護器-拉開器，硬質，小（cl401）；Alexis 補光式傷口保護器-拉開器，硬質，中（cl402）；Alexis 補光式傷口保護器-拉開器，硬質，大（cl403）K252412Voyant® 電外科電流發生器 (EA030/電外科電流發生器)K232880Inzii Ripstop 可重部署回收系統K222284Voyant Maryland 熔合設備，單步啟動功能（EB212、EB213、EB214）K220969GelPOINT V-Path 陰道進入系統K211043Alexis 含有式抽提系統

查看所有 12 項裝置 →

相關器械（代碼：KGW）

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。

K260982Alexis 補光式傷口保護器-拉開器，柔軟，特小（cl312）；Alexis 補光式傷口保護器-拉開器，柔軟，小（cl301）；Alexis 補光式傷口保護器-拉開器，柔軟，中（cl302）；Alexis 補光式傷口保護器-拉開器，柔軟，大（cl303）；Alexis 補光式傷口保護器-拉開器，硬質，小（cl401）；Alexis 補光式傷口保護器-拉開器，硬質，中（cl402）；Alexis 補光式傷口保護器-拉開器，硬質，大（cl403）Applied Medical Resources Corporation

官方來源

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