FDA 510(k)

Giftlife單腔卵母細胞採集針，Giftlife雙腔卵母細胞採集針

K 號：K253121 · 2026-06-15

申請人Gimbo Medical Technology Shenzhen Co., Ltd.

決定日期2026-06-15

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

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle is the device name listed in this FDA 510(k) record. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253121. 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 Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle?

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K253121.

When did Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle receive FDA 510(k) clearance?

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253121.

Who is the listed applicant for Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle?

The FDA 510(k) record lists Gimbo Medical Technology Shenzhen Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle?

The FDA product code for Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle is MQE.

其他以 Gimbo Medical Technology Shenzhen Co., 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。

K242043精子冷凍介質 K242968Giftlife®單步中量加大版 K240002G-Vitri™ 冷凍針 K240149Giftlife™ 稚化培養基；Giftlife™ 裂解培養基；Giftlife™ 細胞胚培養基；Giftlife™ 簡化培養基 K234023卵母細胞灌洗與回收濾液；配子緩冲劑 K232942G-Vitri™ 經濟凍結媒質；G-Vitri™ 經濟凍結解凍媒質

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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。

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.K171625單腔卵子吸取針Willian A. Cook Australia Pty, Ltd.

官方來源

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