FDA 510(k)

RELiZORB (100300/100301)

K 號：K250499 · 2025-04-17

決定日期2025-04-17

產品代碼PLQ

諮詢委員會GU

決定相當於

器材摘要

RELiZORB (100300/100301) is the device name listed in this FDA 510(k) record. The listed applicant is Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K250499. The device is classified under product code PLQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RELiZORB (100300/100301)?

RELiZORB (100300/100301) is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K250499.

When did RELiZORB (100300/100301) receive FDA 510(k) clearance?

RELiZORB (100300/100301) received FDA 510(k) clearance on 2025-04-17, under 510(k) number K250499.

Who is the listed applicant for RELiZORB (100300/100301)?

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

What is the FDA product code for RELiZORB (100300/100301)?

The FDA product code for RELiZORB (100300/100301) is PLQ.

其他以 Alcresta Therapeutics, 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。

K243284RELiZORB (100300/ 100301)K232784RELiZORB®K231156酶填充針筒 - RELiZORB K191379RELiZORB K163057Relizorb K161247Relizorb

查看所有 7 項裝置 →

相關器械（代碼：PLQ）

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。

K243284RELiZORB (100300/ 100301)Alcresta Therapeutics, Inc.K232784RELiZORB®Alcresta Therapeutics, Inc.K231156酶填充針筒 - RELiZORBAlcresta Therapeutics, Inc.K191379RELiZORBAlcresta Therapeutics, Inc.K163057RelizorbAlcresta Therapeutics, Inc.K161247RelizorbAlcresta Therapeutics, 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。