FDA 510(k)

CrossBay 子宮內膜組織採集器 (ETS)

K 號：K192534 · 2020-03-25

決定日期2020-03-25

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

CrossBay Endometrial Tissue Sampler (ETS) is the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192534. 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 CrossBay Endometrial Tissue Sampler (ETS)?

CrossBay Endometrial Tissue Sampler (ETS) is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Crossbay Medical. The 510(k) number is K192534.

When did CrossBay Endometrial Tissue Sampler (ETS) receive FDA 510(k) clearance?

CrossBay Endometrial Tissue Sampler (ETS) received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192534.

Who is the listed applicant for CrossBay Endometrial Tissue Sampler (ETS)?

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

What is the FDA product code for CrossBay Endometrial Tissue Sampler (ETS)?

The FDA product code for CrossBay Endometrial Tissue Sampler (ETS) is HHK.

其他以 Crossbay Medical 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。

K201952CrossGlide ETS Plus K190813CrossBay 子宮頸擴張導尿管系統

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。

K251882子宮吸引器組Gcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV 吸附刮刀（柔軟型 3.0/標準型 3.6）Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay Medical

官方來源

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