FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K Number: K253255
·
Decision Jun 17, 2026
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
3
Review Days
261
Basic Information
- Device Name
- Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
- K Number
- K253255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Foshan Pingchuang Medical Technology Co., Ltd.
- Date Received
- September 29, 2025
- Decision Date
- June 17, 2026
- Product Code
- MUI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
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Other Clearances by Foshan Pingchuang Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Dec 15, 2025 | Substantially Equivalent |
| K212104 | Water-soluble Personal Lubricant | Nov 18, 2021 | Substantially Equivalent |