FDA 510(k)

G-Vitri™ 冷凍針

K 號：K240002 · 2024-06-14

申請人Gimbo Medical Technology Shenzhen Co., Ltd.

決定日期2024-06-14

產品代碼MQK

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

G-Vitri™ Vitrification Straw 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 2024-06-14 under 510(k) number K240002. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the G-Vitri™ Vitrification Straw?

G-Vitri™ Vitrification Straw is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K240002.

When did G-Vitri™ Vitrification Straw receive FDA 510(k) clearance?

G-Vitri™ Vitrification Straw received FDA 510(k) clearance on 2024-06-14, under 510(k) number K240002.

Who is the listed applicant for G-Vitri™ Vitrification Straw?

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 G-Vitri™ Vitrification Straw?

The FDA product code for G-Vitri™ Vitrification Straw is MQK.

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。

K253121Giftlife單腔卵母細胞採集針，Giftlife雙腔卵母細胞採集針 K242043精子冷凍介質 K242968Giftlife®單步中量加大版 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：MQK）

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。

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