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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K253121

510(k) cleared

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Gimbo Medical Technology Shenzhen Co., Ltd. · Jun 15, 2026 · K253121

FDA cleared the Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle from Gimbo Medical Technology Shenzhen Co., Ltd. on Jun 15, 2026 under K253121, a traditional 510(k). The device falls under product code MQE, Needle, Assisted Reproduction, regulated at 21 CFR 884.6100 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 25, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gimbo Medical Technology Shenzhen Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253121?

K253121 is the FDA 510(k) for Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle, submitted by Gimbo Medical Technology Shenzhen Co., Ltd.. FDA's decision date was Jun 15, 2026, under product code MQE (Needle, Assisted Reproduction).

Who makes the Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle?

Gimbo Medical Technology Shenzhen Co., Ltd., based in Shezhen, is the applicant of record for K253121.

How long did the K253121 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Jun 15, 2026, 263 days later.

← All decisions in June 2026