FDA 510(k)

單腔卵子吸取針

K 號：K171625 · 2018-01-12

決定日期2018-01-12

產品代碼MQE

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

Single Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171625. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single Lumen Ovum Aspiration Needles?

Single Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K171625.

When did Single Lumen Ovum Aspiration Needles receive FDA 510(k) clearance?

Single Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171625.

Who is the listed applicant for Single Lumen Ovum Aspiration Needles?

The FDA 510(k) record lists Willian A. Cook Australia Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Lumen Ovum Aspiration Needles?

The FDA product code for Single Lumen Ovum Aspiration Needles is MQE.

其他以 Willian A. Cook Australia Pty, 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。

K152682悉尼IVF冷凍儲存套件，悉尼IVF解凍套件

相關器械（代碼：MQE）

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。

K253121Giftlife單腔卵母細胞採集針，Giftlife雙腔卵母細胞採集針Gimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro®單腔卵母細胞採集針（ORNS-17G、ORNS-18G），VitaVitro®雙腔卵母細胞採集針（ORND-17G）Shenzhen Vitavitro Biotech Co., Ltd.K232163蓮花單腔卵子抽吸針；蓮花雙腔卵子抽吸針Zhejiang Horizon Medical Technology Co., Ltd.K190590Allwin卵子拾取針（ACE單腔卵子拾取針，OVUMPICK雙腔卵子拾取針，ACE-FL單腔卵子拾取針帶灌洗管，ACE-M手動單腔卵子拾取針）Allwin Medical Devices, Inc.K191291華萊士雙腔卵母細胞回收系統CooperSurgical, Inc.K182959華萊士雙腔卵母細胞回收系統CooperSurgical, Inc.

官方來源

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