FDA 510(k)

EdgeFlow 輔助墊

K 號：K252337 · 2026-04-24

決定日期2026-04-24

產品代碼MUI

諮詢委員會RA

決定相當於

器材摘要

EdgeFlow Gel Pad is the device name listed in this FDA 510(k) record. The listed applicant is Edgecare, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K252337. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EdgeFlow Gel Pad?

EdgeFlow Gel Pad is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Edgecare, Inc.. The 510(k) number is K252337.

When did EdgeFlow Gel Pad receive FDA 510(k) clearance?

EdgeFlow Gel Pad received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252337.

Who is the listed applicant for EdgeFlow Gel Pad?

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

What is the FDA product code for EdgeFlow Gel Pad?

The FDA product code for EdgeFlow Gel Pad is MUI.

其他以 Edgecare, Inc. 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。

K252237EdgeFlow UW20 K231677EdgeFlow UH10

相關器械（代碼：MUI）

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。

K253255非无菌超音波膠點菌超音波膠Foshan Pingchuang Medical Technology Co., Ltd.K242167無菌及非无菌式超音波耦合劑Anhui Deepblue Medical Technology Co., Ltd.K241789非無菌超聲傳播膠Hony Medical Co., Ltd.K232957無菌及非无菌超音波膠Jianerkang Medical Co., Ltd.K221999超音波傳遞膠Hony Medical Co., Ltd.K211691超聲波膠Ultrast, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。