FDA 510(k)

子宮吸引器組

K 號：K251882 · 2025-10-16

決定日期2025-10-16

產品代碼HHK

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

Uterine Aspiration Set is the device name listed in this FDA 510(k) record. The listed applicant is Gcmedica Enterprise Ltd.(Wuxi). It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K251882. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Uterine Aspiration Set?

Uterine Aspiration Set is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Gcmedica Enterprise Ltd.(Wuxi). The 510(k) number is K251882.

When did Uterine Aspiration Set receive FDA 510(k) clearance?

Uterine Aspiration Set received FDA 510(k) clearance on 2025-10-16, under 510(k) number K251882.

Who is the listed applicant for Uterine Aspiration Set?

The FDA 510(k) record lists Gcmedica Enterprise Ltd.(Wuxi) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uterine Aspiration Set?

The FDA product code for Uterine Aspiration Set is HHK.

其他以 Gcmedica Enterprise Ltd.(Wuxi) 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。

K182819分裝設備

相關器械（代碼：HHK）

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。

K240434RELIEEV 吸附刮刀（柔軟型 3.0/標準型 3.6）Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay Medical K192534CrossBay 子宮內膜組織採集器 (ETS)Crossbay Medical

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。