510(k) K253255

Non-Sterile Ultrasound Gel Sterile Ultrasound Gel by Foshan Pingchuang Medical Technology Co., Ltd. — Product Code MUI

K253255 is an FDA 510(k) premarket notification submitted by Foshan Pingchuang Medical Technology Co., Ltd. for the device "Non-Sterile Ultrasound Gel Sterile Ultrasound Gel". The FDA issued a decision of Substantially Equivalent on June 17, 2026. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Foshan Pingchuang Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.