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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 / September 2025 / K251773

510(k) cleared

Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)

Shenzhen Yongquan Medical Devices Co., Ltd. · Sep 9, 2025 · K251773

FDA cleared the Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) from Shenzhen Yongquan Medical Devices Co., Ltd. on Sep 9, 2025 under K251773, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 10, 2025. The decision came 91 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 Shenzhen Yongquan Medical Devices Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251773?

K251773 is the FDA 510(k) for Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.), submitted by Shenzhen Yongquan Medical Devices Co., Ltd.. FDA's decision date was Sep 9, 2025, under product code NUC (Lubricant, Personal).

Who makes the Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)?

Shenzhen Yongquan Medical Devices Co., Ltd., based in Shenzhen, is the applicant of record for K251773.

How long did the K251773 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Sep 9, 2025, 91 days later.

← All decisions in September 2025