510(k) clearance
AutoGel Pad (400-046,400-005)
- 510(k) number
- K260575
- Applicant
- Top-Rank Health Care Co., Ltd.
- Decision date
- Oct 30, 2026
- Date received
- Feb 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MUI
- Device type
- Media, Coupling, Ultrasound
- Device class
- Class II
- Regulation
- 21 CFR 892.1570
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shaoxing, CN