EdgeFlow Gel Pad— 510(k) K252337
Substantially EquivalentEdgecare, Inc.
FDA 510(k) clearance K252337 for EdgeFlow Gel Pad, Substantially Equivalent on 2026-04-24. Applicant: Edgecare, Inc.. Device class: 2.
Summary
Edgecare's EdgeFlow Gel Pad is filed under product code MUI (Media, Coupling, Ultrasound).
Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Edgecare filed from Seoul, South Korea. The decision came 270 calendar days after FDA received it (July 28, 2025 to April 24, 2026).
Clearance details
- Applicant
- Edgecare, Inc.
- 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
- Seoul, KR
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