FDA 510(k)

RELIEEV 子宮操作注射器（CUMI 5.0）

K 號：K240364 · 2024-10-16

決定日期2024-10-16

產品代碼LKF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

RELIEEV Uterine Manipulator Injector (CUMI 5.0) is the device name listed in this FDA 510(k) record. The listed applicant is Li Medical Corporation , Ltd.. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K240364. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

RELIEEV Uterine Manipulator Injector (CUMI 5.0) is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Li Medical Corporation , Ltd.. The 510(k) number is K240364.

When did RELIEEV Uterine Manipulator Injector (CUMI 5.0) receive FDA 510(k) clearance?

RELIEEV Uterine Manipulator Injector (CUMI 5.0) received FDA 510(k) clearance on 2024-10-16, under 510(k) number K240364.

Who is the listed applicant for RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

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

What is the FDA product code for RELIEEV Uterine Manipulator Injector (CUMI 5.0)?

The FDA product code for RELIEEV Uterine Manipulator Injector (CUMI 5.0) is LKF.

其他以 Li Medical Corporation , 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。

K252260RELIEEV HSG 腹腔鏡導管 (HSG7FA1)K240434RELIEEV 吸附刮刀（柔軟型 3.0/標準型 3.6）

相關器械（代碼：LKF）

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。

K253403FemVue® 控制鹽水-空氣設備 (FSA-300)Femasys, Inc.K252260RELIEEV HSG 腹腔鏡導管 (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI鹽水-空氣設備Femasys, Inc.K241693FemChec 控制鹽水-空氣設備 (FCD-250)Femasys, Inc.K222798Rejoni 子宮內腔導管Rejoni, Inc.K223064ALLY II 子宮定位系統™ (UPS)CooperSurgical, 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。