510(k) K252337
K252337 is an FDA 510(k) premarket notification submitted by Edgecare, Inc. for the device "EdgeFlow Gel Pad". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Edgecare, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2026
- Date Received
- July 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Coupling, Ultrasound
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type