Non-Sterile Ultrasound Gel Sterile Ultrasound Gel— 510(k) K253255
Substantially EquivalentFoshan 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.
Summary
Foshan Pingchuang Medical Technology's device name reads "Non-Sterile Ultrasound Gel Sterile Ultrasound Gel," which appears to cover non-sterile and sterile versions of an ultrasound gel. It's filed under MUI, ultrasound coupling media, and the record gives no other description.
Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Pingchuang filed from Foshan, China. Review took 261 calendar days (September 29, 2025 to June 17, 2026).
Clearance details
- Applicant
- Foshan Pingchuang Medical Technology Co., Ltd.
- Product code
- Product code MUI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
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