Non-Sterile Ultrasound Gel Sterile Ultrasound Gel— 510(k) K253255

Name: FDA 510(k) clearance K253255
Creator: U.S. Food and Drug Administration
Published: 2026-06-17

Substantially Equivalent

Foshan Pingchuang Medical Technology Co., Ltd.

FDA 510(k) clearance K253255 for Non-Sterile Ultrasound Gel Sterile Ultrasound Gel, Substantially Equivalent on 2026-06-17. Applicant: Foshan Pingchuang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Foshan Pingchuang Medical Technology Co., Ltd.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2025-09-29
Decision date: 2026-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

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