K253255
- 510(k) number
- K253255
- Device name
- Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
- Applicant
- Foshan Pingchuang Medical Technology Co., Ltd. CN
- Product code
- MUI — Media, Coupling, Ultrasound
- Decision date
- 2026-06-17
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253255.pdf
Official FDA record: K253255
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.