510(k) K253121

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle by Gimbo Medical Technology Shenzhen Co., Ltd. — Product Code MQE

K253121 is an FDA 510(k) premarket notification submitted by Gimbo Medical Technology Shenzhen Co., Ltd. for the device "Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle". The FDA issued a decision of Substantially Equivalent on June 15, 2026. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Gimbo Medical Technology Shenzhen Co., Ltd. has at least 6 other 510(k) clearances on record.