每周期可重用衛生棉棒施用器
K 號：K211519 · 2021-08-13
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申請人Cycle, LLC
決定日期2021-08-13
產品代碼HEB
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
Every Cycle Reusable Tampon Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Cycle, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211519. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Every Cycle Reusable Tampon Applicator?
Every Cycle Reusable Tampon Applicator is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Cycle, LLC. The 510(k) number is K211519.
When did Every Cycle Reusable Tampon Applicator receive FDA 510(k) clearance?
Every Cycle Reusable Tampon Applicator received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211519.
Who is the listed applicant for Every Cycle Reusable Tampon Applicator?
The FDA 510(k) record lists Cycle, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Every Cycle Reusable Tampon Applicator?
The FDA product code for Every Cycle Reusable Tampon Applicator is HEB.
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。
相關器械（代碼：HEB）
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。
K252005Livi 裝置Liviwell, Inc.K253719無香月經長型置入器衛生棉條；無香月經紙盒置入器衛生棉條；無香月經數位衛生棉條Unibeauty (Hubei) Technology Co., Ltd.K252939COHITECH 有機棉緊湊式膠囊棒針Cotton High Tech S.L.K252613無香月經三件式推入式衛生棉棒Unibeauty (Hubei) Technology Co., Ltd.K251033無香月經長型針筒式衛生棉棒；無香月經精巧針筒式衛生棉棒；無香月經紙盒針筒式衛生棉棒；無香月經數位衛生棉棒Unibeauty (Hubei) Technology Co., Ltd.K242105SABA 月經棉棒Essity Higiene Y Salud Mexico. S.A. DE C.V.
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。
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