FDA 510(k)

Giftlife单腔卵母细胞采集针，Giftlife双腔卵母细胞采集针

K号: K253121 · 2026-06-15

申请人Gimbo Medical Technology Shenzhen Co., Ltd.

决定日期2026-06-15

产品代码MQE

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决定实质等同

器械摘要

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.

常见问题

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.

列明Gimbo Medical Technology Shenzhen Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242043精子冷冻介质 K242968Giftlife® 单步中号加强型 K240002G-Vitri™玻璃化吸管 K240149Giftlife™受精介质；Giftlife™分裂介质；Giftlife™囊胚介质；Giftlife™单步介质 K234023卵母细胞冲洗与采集介质；配子缓冲液 K232942G-Vitri™玻璃化冷冻介质；G-Vitri™玻璃化解冻介质

查看所有 7 个设备 →

相关器械（代码：MQE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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