K252337
- 510(k) number
- K252337
- Device name
- EdgeFlow Gel Pad
- Applicant
- Edgecare, Inc. KR
- Product code
- MUI — Media, Coupling, Ultrasound
- Decision date
- 2026-04-24
- Date received
- 2025-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252337.pdf
Official FDA record: K252337
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.