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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 / K253255

510(k) cleared

Non-Sterile Ultrasound Gel Sterile Ultrasound Gel

Foshan Pingchuang Medical Technology Co., Ltd. · Jun 17, 2026 · K253255

FDA cleared the Non-Sterile Ultrasound Gel Sterile Ultrasound Gel from Foshan Pingchuang Medical Technology Co., Ltd. on Jun 17, 2026 under K253255, a traditional 510(k). The device falls under product code MUI, Media, Coupling, Ultrasound, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Foshan Pingchuang Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252935 (Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)).

Questions & Answers

What did FDA clear under K253255?

K253255 is the FDA 510(k) for Non-Sterile Ultrasound Gel Sterile Ultrasound Gel, submitted by Foshan Pingchuang Medical Technology Co., Ltd.. FDA's decision date was Jun 17, 2026, under product code MUI (Media, Coupling, Ultrasound).

Who makes the Non-Sterile Ultrasound Gel Sterile Ultrasound Gel?

Foshan Pingchuang Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K253255.

How long did the K253255 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 17, 2026, 261 days later.

← All decisions in June 2026

Sources